FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Stent, Coronary
PMA: P910030
·
Decision Feb 8, 1993
Classifications
1
FEI Numbers
28
Registration Numbers
28
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
- PMA Number
- P910030
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- February 8, 1993
- Date Received
- June 6, 1991
- Expedited Review
- N
- Docket Number
- 93M-0212
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 |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |