FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Replacement Heart-Valve
PMA: P860057
·
Supplement: S223
·
Decision Oct 16, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Replacement Heart-Valve
- Trade Name
- Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi
- PMA Number
- P860057
- Supplement Number
- S223
- Device Class
- FDA Class 3
- Product Code
- DYE
- Generic Name
- replacement Heart-valve
- Regulation Number
- 870.3925
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 16, 2025
- Date Received
- September 16, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
addition of final bioburden reduction and preliminary packaging processes to an existing cleanroom, and increased maximum capacity in the cleanroom
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYE | Replacement Heart-Valve | FDA class 3 | Cardiovascular |