PMA P910001S033
- Device
- CVX-300 LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S033
- Product code
- LPC
- Decision date
- 2010-07-08
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR CHANGES TO THE CVX-300 EXCIMER LASER SYSTEM FOR COMPLIANCE TO ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY VOLUNTARY STANDARDS.
Current openFDA PMA Record#
- Device
- CVX-300 LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S033
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2010-07-08
- Decision code
- APPR
- Date received
- 2009-09-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE CVX-300 EXCIMER LASER SYSTEM FOR COMPLIANCE TO ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY VOLUNTARY STANDARDS.