Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve
FDA premarket approval P150011/S028 · decided 2025-03-12
Approval details
- PMA number
- P150011
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym S.r.l.
- Date received
- 2024-07-18
- Decision date
- 2025-03-12
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- approval for the following manufacturing site: Corcym S.r.l, Via Crescentino sn, 13040 Saluggia (VC) ITALY, Operations to be performed: manufacturing, packaging, sterilization
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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 |