FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Carotid
PMA: P060001
·
Supplement: S053
·
Decision Dec 16, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P060001 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
- Stent, Carotid
- Trade Name
- Protégé GPS Self-expanding Peripheral Stent System
- PMA Number
- P060001
- Supplement Number
- S053
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 16, 2025
- Date Received
- December 8, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to modify the injection overmolding process parameters at a supplier for a catheter component
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 |
|---|---|---|---|
| NIM | Stent, Carotid | FDA class 3 | Unknown |