CARBOMEDICS PROSTHETIC HEART VALVE
FDA premarket approval P900060/S022 · decided 2001-02-16
Approval details
- PMA number
- P900060
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2001-01-22
- Decision date
- 2001-02-16
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- INCREASING THE STERILIZATION LOAD SIZE FOR CPHV(TM) AND UTILIZE MIXED LOADS OF CPHV(TM) AND ANNULOPLASTY RINGS (ANNULOFLO(R), AND/OR ANNULOFLEX(TM), TO MAXIMUM OF 384 BARRIERS IN THE SAME CYCLE AT TH EAUSTIN AND CALGARY FACILITIES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707) | Corcym S.r.l. | 2026-06-18 |
| TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498) | Corcym S.r.l. | 2026-04-14 |
| Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318) | Corcym S.r.l. | 2023-04-07 |