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Abbott Medical: FDA-registered device maker in Penang Pulau Pinang, Malaysia, 5 510(k) clearances and 9 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 3008494315) in Penang Pulau Pinang, Malaysia. It lists 15 device types. The FDA files 5 510(k) clearances and 9 PMA approvals under its listings, the newest dated May 17, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008494315
FEI number: 3008377825
Address: Plot 102, Lebuhraya Kampung Jawa Bayan Lepas Industrial Zone, Penang Pulau Pinang, Malaysia, 11900
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer
First device listed: May 22, 2006
Registered through: 2027
Brand names listed: Accent; Sustain XL SC, DC, SR, DR;, Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers, Assert-IQ 3, 3+, EL, Insertion and Incision Tools - Models DM5000, DM5300, DM5500, DM5310, DM5510, DM5320, Avant Models - CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T, Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T, CRT Leads, Quickflex Left Heart Leads, Confirm Rx, Confirm Rx ICM Accessory Kit 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
Detector And Alarm, Arrhythmia	DSI	2	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
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
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
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	MXC	2	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 17, 2023	K230286	Assert-IQ Insertable Cardiac Monitor	MXC	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
August 13, 2021	K212206	Jot Dx Insertable Cardiac Monitor	MXC	Substantially Equivalent	Abbott (St. Jude Medical)	accessdata.fda.gov
December 1, 2020	K202876	Confirm Rx Insertable Cardiac Monitor	MXC	Substantially Equivalent	Abbott (St. Jude Medical)	accessdata.fda.gov
November 23, 2020	K202888	Confirm Rx Insertable Cardiac Monitor	MXC	Substantially Equivalent	Abbott (St. Jude Medical)	accessdata.fda.gov
September 29, 2017	K163407	Confirm Rx Insertable Cardiac Monitor (ICM) System	MXC	Substantially Equivalent	St. Jude Medical, 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
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 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
December 21, 2000	P970013	MICRONY PACEMAKERS	LWO	94	July 21, 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

Compare with other makers

Updated July 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.