FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Heart-Valve, Mechanical
PMA: P810002
·
Supplement: S125
·
Decision Oct 15, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Heart-Valve, Mechanical
- Trade Name
- Masters Series Mechanical Heart Valve
- PMA Number
- P810002
- Supplement Number
- S125
- Device Class
- FDA Class 3
- Product Code
- LWQ
- Generic Name
- HEART-VALVE, MECHANICAL
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 15, 2025
- Date Received
- September 18, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a change to the endotoxin extraction sample preparation method and to add the PyroGene endotoxin test method to detect bacterial endotoxins
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 |
|---|---|---|---|
| LWQ | Heart-Valve, Mechanical | FDA class 3 | Unknown |