Perceval PLUS Sutureless Heart Valve
FDA premarket approval P150011/S024 · decided 2022-10-07
Approval details
- PMA number
- P150011
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Perceval PLUS Sutureless Heart Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym S.r.l.
- Date received
- 2022-04-11
- Decision date
- 2022-10-07
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- approval for the Perceval RelyON PAK Accessories Kit for collapsing and releasing the Perceval PLUS valve and modification to the Instructions for Use to address the use of the new accessories.
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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 |