CARBOMEDICS PROSTHETIC HEART VALVE {CPHV}
FDA premarket approval P900060/S026 · decided 2003-07-25
Approval details
- PMA number
- P900060
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE {CPHV}
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2003-06-27
- Decision date
- 2003-07-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- CHANGE IN THE MANUFACTURING PROCESS OF THE PAPER USED IN THE MANUFACTURE OF THE VENT COVERS INCLUDED IN THE PACKAGING OF THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV).
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510(k) clearances by this applicant
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|---|---|---|
| MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707) | Corcym S.r.l. | 2026-06-18 |
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