FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Device, Angioplasty, Laser, Coronary
PMA: P910001
·
Supplement: S084
·
Decision Apr 7, 2016
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Device, Angioplasty, Laser, Coronary
- Trade Name
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- PMA Number
- P910001
- Supplement Number
- S084
- Device Class
- FDA Class 3
- Product Code
- LPC
- Generic Name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 7, 2016
- Date Received
- March 8, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Changes to the distal jacket manufacturing process.
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 |