PMA P910001S087
- Device
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S087
- Product code
- LPC
- Decision date
- 2016-07-07
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for the Laser Certification Label modification to conform with CDRH recommendations per Laser Notice 50.
Current openFDA PMA Record#
- Device
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S087
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2016-07-07
- Decision code
- APPR
- Date received
- 2016-06-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Laser Certification Label modification to conform with CDRH recommendations per Laser Notice 50.