MicroPort CRM S.r.l.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “MicroPort CRM S.r.l.”, plus 6 PMA decisions, across 5 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | 2 | 0 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 | 0 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 1 | 0 |
| MRM | Defibrillator, Implantable, Dual-Chamber | 1 | 0 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 1 | 0 |
Review panels
- Cardiovascular (6)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130010 | PMA | VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) | 2023-05-17 |
| P060027 | PMA | OVATIO CRT SYSTEM | 2008-05-15 |
| P020030 | PMA | STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD | 2004-06-17 |
| P980049 | PMA | DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 1999-09-15 |
| P950029 | PMA | CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER | 1997-03-10 |
Recalls
FDA recall records list no recalls under a recalling firm named MicroPort CRM S.r.l..
23 product recalls in 12 recall events filed under other recalling-firm names cite a 510(k) or PMA held under this applicant name; 0 initiated in the last five years. Most often: Sorin Group Italia SRL - CRF (9), ela Medical Llc (8), Sorin Group USA, Inc. (3).
These recall records list the clearance number, so the device was cleared under this name. The recalling firm may be the same company under another spelling, a company that acquired the product line, a relabeler or a contract manufacturer. They are not added to the count above.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under MicroPort CRM S.r.l. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Microport Orthopedics, Inc. (40 510(k)s)
- MicroPort NeuroTech (Shanghai) Co., Ltd. (4 510(k)s)
- Microport Navibot International, LLC (1 510(k)s)
- Microport Orthopedics Inc. (Mpo) (1 510(k)s)
- MicroPort CRM USA, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under MicroPort CRM S.r.l.?
FDA lists 0 510(k) clearances under the applicant name “MicroPort CRM S.r.l.”, plus 6 PMA decisions, across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under MicroPort CRM S.r.l.?
The most frequent FDA product codes under this applicant name are NVN (Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes, 2); DXY (Implantable Pacemaker Pulse-Generator, 1); LWP (Implantable Pulse Generator, Pacemaker (Non-Crt), 1).
Next steps
- See all 0 MicroPort CRM S.r.l. clearances with predicates and recalls
- Run predicate analysis for product code NVN, MicroPort CRM S.r.l.'s most frequent
Compiled by Caduvo from public U.S. government records. Counts cover filings under the applicant name shown on this page only. Review days run from FDA receipt to decision. Not reviewed or endorsed by FDA or any other agency, or by the companies named. Not regulatory advice. Report an error in this data. Data and corrections policy.