FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Replacement Heart-Valve
PMA: P990064
·
Supplement: S093
·
Decision Nov 10, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P990064 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Replacement Heart-Valve
- Trade Name
- Mosaic Bioprosthesis
- PMA Number
- P990064
- Supplement Number
- S093
- Device Class
- FDA Class 3
- Product Code
- DYE
- Generic Name
- replacement Heart-valve
- Regulation Number
- 870.3925
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 10, 2025
- Date Received
- August 13, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for implementation of updates to the product labels and IFUs, and the implementation of a new temperature indicator on the secondary package shelf cartons for the Mosaic, Hancock II, Avalus, and Freestyle bioprostheses
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 |