FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Mitral Valve Repair Devices
PMA: P100009
·
Supplement: S079
·
Decision Aug 18, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Mitral Valve Repair Devices
- Trade Name
- MitraClip Delivery System
- PMA Number
- P100009
- Supplement Number
- S079
- Device Class
- FDA Class 3
- Product Code
- NKM
- Generic Name
- Mitral valve repair devices
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 18, 2025
- Date Received
- July 21, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to change the incoming inspection sampling plan for components of the TriClip and MitraClip Delivery Systems from an Attribute Acceptable Quality Limit (AQL) to a variable-based plan with custom sampling plan requirements
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 |
|---|---|---|---|
| NKM | Mitral Valve Repair Devices | FDA class 3 | Unknown |