FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P980037
·
Supplement: S095
·
Decision Aug 1, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- AngioJet Thrombectomy System
- PMA Number
- P980037
- Supplement Number
- S095
- Device Class
- FDA Class 3
- Product Code
- MCX
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 1, 2025
- Date Received
- July 11, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
implementing final functional re-testing at the Dorado facility
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 |
|---|---|---|---|
| MCX | Catheter, Coronary, Atherectomy | FDA class 3 | Unknown |