FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P900056
·
Supplement: S002
·
Decision Jan 10, 1994
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- ROTABLATOR(R)
- PMA Number
- P900056
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- MCX
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 10, 1994
- Date Received
- July 23, 1993
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
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 |