FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P900056
·
Supplement: S222
·
Decision Oct 27, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P900056 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
- Catheter, Coronary, Atherectomy
- Trade Name
- ROTAPRO Rotational Atherectomy System
- PMA Number
- P900056
- Supplement Number
- S222
- 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
- October 27, 2025
- Date Received
- September 30, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a mold change/optimization and manufacturing update to improve the manufacturability of the Advancer Knob
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 |