Data / Medical devices / United States / Abbott Medical

Abbott Medical: FDA-registered device maker in Arecibo, PR, United States, 1 510(k) clearance and 12 PMA approvals

Name: Abbott Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Abbott Medical is registered with the FDA (registration 3006705815) in Arecibo, PR, United States. It lists 21 device types. The FDA files 1 510(k) clearance and 12 PMA approvals under its listings, the newest dated March 31, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006705815
Address: LOT A INTERIOR - No. 2 RD KM 67.5 SANTANA INDUSTRIAL PARK, Arecibo, PR, United States, 00612
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Contract sterilizer, Manufacturer
First device listed: May 22, 2006
Registered through: 2027
Brand names listed: 4 Channel DBS Extension, 4 Channel DBS Lead, 8-Channel Adapter, 8-Channel Adapter (Model 2311, 2316), 8-Channel Adapter, B, 10cm (Model 2321), 8-Channel Adapter, B, 60cm (Model 2326), A127 Lead Extension, AVEIR AR 2 Leadless Pacemaker - Model LSP203A and more

Devices it lists

Device	Product code	Class	Role	Source
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	NIK	3	Manufacturer	accessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	OJX	3	Manufacturer	accessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	NVN	3	Manufacturer	accessdata.fda.gov
Heart-Valve, Mechanical	LWQ	3	Contract sterilizer	accessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)	LWS	3	Manufacturer	accessdata.fda.gov
Implantable Pacemaker Pulse-Generator	DXY	3	Manufacturer	accessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)	LWP	3	Manufacturer	accessdata.fda.gov
Leadless Pacemaker	PNJ	3	Manufacturer	accessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted Components	OSR	3	Manufacturer	accessdata.fda.gov
Permanent Defibrillator Electrodes	NVY	3	Manufacturer	accessdata.fda.gov
Permanent Pacemaker Electrode	DTB	3	Manufacturer	accessdata.fda.gov
Programmer, Pacemaker	KRG	3	Manufacturer	accessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	NKE	3	Manufacturer	accessdata.fda.gov
Pulse Generator, Permanent, Implantable	NVZ	3	Manufacturer	accessdata.fda.gov
Pulse-Generator, Single Chamber, Sensor Driven, Implantable	LWO	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential Tremor	PJS	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	NHL	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Tremor	MHY	3	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Implanted (Pain Relief)	GZB	2	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	LGW	3	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	QRB	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 22, 1996	K960728	ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)	GZB	Substantially Equivalent	Neuromed, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 31, 2022	P150035	Aveir VR Leadless System	PNJ	42	October 21, 2026	accessdata.fda.gov
January 31, 2017	P140033	Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software	LWP	100	July 21, 2026	accessdata.fda.gov
June 12, 2015	P140009	BRIO NEUROSTIMULATION SYSTEM	MHY	135	September 23, 2026	accessdata.fda.gov
June 30, 2004	P030054	ST JUDE MEDICAL EPIC HF SYSTEM	NIK	427	August 12, 2026	accessdata.fda.gov
May 13, 2004	P030035	ANTHEM AND FRONTIER II CRT-P'S	NKE	202	July 21, 2026	accessdata.fda.gov
November 21, 2001	P010032	GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS	LGW	244	September 23, 2026	accessdata.fda.gov
January 29, 1998	P960030	PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS	NVN	81	June 26, 2026	accessdata.fda.gov
June 20, 1997	P960013	TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS	NVN	130	October 9, 2026	accessdata.fda.gov
May 10, 1996	P950022	TVL(TM) LEAD SYSTEM	LWS	145	June 26, 2026	accessdata.fda.gov
April 30, 1993	P910023	CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM	LWS	461	August 12, 2026	accessdata.fda.gov
August 21, 1989	P880086	ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS	DXY	328	July 21, 2026	accessdata.fda.gov
February 28, 1989	P880006	SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM	DXY	86	February 12, 2016	accessdata.fda.gov

Compare with other makers

Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.