PMA P910001S008
- Device
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S008
- Product code
- LPC
- Decision date
- 1995-07-12
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR UPGRADED SOFTWARE (VERSION 3.4) FOR THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
Current openFDA PMA Record#
- Device
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S008
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 1995-07-12
- Decision code
- APPR
- Date received
- 1994-05-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPGRADED SOFTWARE (VERSION 3.4) FOR THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM