Data / Medical devices / Italy / MicroPort CRM S.r.l.
MicroPort CRM S.r.l.: FDA-registered device maker in Saluggia (VC) Vercelli, Italy, 2 510(k) clearances and 4 PMA approvals
MicroPort CRM S.r.l. is registered with the FDA (registration 1000165971) in Saluggia (VC) Vercelli, Italy. It lists 12 device types. The FDA files 2 510(k) clearances and 4 PMA approvals under its listings, the newest dated May 17, 2023. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000165971
- Address
- Via Crescentino s.n, Saluggia (VC) Vercelli, Italy, 13040
- Owner or operator
- MicroPort CRM S.R.L. (9059364)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- August 21, 2009
- Registered through
- 2026
- Brand names listed
- ALIZEA DR 1600, ALIZEA SR 1300, Accessory for pacemaker, ICD and CRT-D Permanent magnet, Accessory for pacemaker, ICD and CRT-D Screw driver, CELEA DR 1400, CELEA SR 1100, CPR3 telemetry wand (Accessory to SmartView Hotspot), CPR4 and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 20, 2004 | K042002 | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER | DQK | Substantially Equivalent | Ela Medical, Inc. | accessdata.fda.gov |
| August 22, 2003 | K032466 | SPIDERVIEW | MWJ | Substantially Equivalent | Ela 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 |
|---|---|---|---|---|---|---|
| May 17, 2023 | P130010 | VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) | NVN | 5 | January 15, 2026 | accessdata.fda.gov |
| May 15, 2008 | P060027 | OVATIO CRT SYSTEM | NIK | 104 | November 25, 2025 | accessdata.fda.gov |
| September 15, 1999 | P980049 | DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | MRM | 145 | November 25, 2025 | accessdata.fda.gov |
| March 10, 1997 | P950029 | CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER | DXY | 128 | July 23, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 24, 2017 | 77983 | Class II | Terminated | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PL | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. | accessdata.fda.gov |
| April 11, 2017 | 77139 | Class II | Terminated | OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for us | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | accessdata.fda.gov |
| November 20, 2013 | 67013 | Class II | Terminated | ORCHESTRA/ORCHESTRA PLUS Programmer | Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker. | accessdata.fda.gov |
Compare with other makers
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
- All makers of Implantable Pacemaker Pulse-Generator
- All makers of Pacemaker/Icd/Crt Non-Implanted Components
- All makers of Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated January 15, 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.