FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P890043
·
Decision Sep 14, 1990
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- SIMPSON CORONARY ATHEROCATH(TM)
- PMA Number
- P890043
- Device Class
- FDA Class 3
- Product Code
- MCX
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 14, 1990
- Date Received
- August 18, 1989
- Expedited Review
- N
- Docket Number
- 90M-0318
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 |