FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Device, Angioplasty, Laser, Coronary
PMA: P870043
·
Decision Jun 30, 1988
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Device, Angioplasty, Laser, Coronary
- Trade Name
- SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER
- PMA Number
- P870043
- 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- Approved (Withdrawn)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
- June 30, 1988
- Date Received
- July 29, 1987
- Expedited Review
- N
- Docket Number
- 88M-0264
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 |