FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P900056
·
Supplement: S224
·
Decision Apr 9, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- Rotablator; ROTAPRO Rotational Atherectomy Systems
- PMA Number
- P900056
- Supplement Number
- S224
- 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
- April 9, 2026
- Date Received
- March 12, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
transfer of manufacturing activities of the ROTAWIRE Drive guidewire and wireClip Torquer guidewire manipulation devices from the BSC Heredia, Costa Rica facility to the BSC Coyol, Costa Rica 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 |