MicroPort CRM USA, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “MicroPort CRM USA, Inc.”, plus 7 PMA decisions, across 6 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 |
| LWS | Implantable Cardioverter Defibrillator (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 (7)
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 |
| P970024 | PMA | ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. | 1998-08-19 |
Recalls
openFDA lists no recalls under a recalling firm named MicroPort CRM USA, Inc..
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 USA, Inc. (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. (39 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under MicroPort CRM USA, Inc.?
FDA lists 0 510(k) clearances under the applicant name “MicroPort CRM USA, Inc.”, plus 7 PMA decisions, across 6 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 USA, Inc.?
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 USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NVN, MicroPort CRM USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.