FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Device, Angioplasty, Laser, Coronary
PMA: P900032
·
Decision Jan 31, 1992
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Device, Angioplasty, Laser, Coronary
- Trade Name
- AIS EXIMER LASER ANGIOPLASTY
- PMA Number
- P900032
- Device Class
- FDA Class 3
- Product Code
- LPC
- Generic Name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- January 31, 1992
- Date Received
- May 2, 1990
- Expedited Review
- N
- Docket Number
- 92M-0078
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 |
|---|---|---|---|
| LPC | Device, Angioplasty, Laser, Coronary | FDA class 3 | Unknown |