PMA P910001S108
- Device
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S108
- Product code
- LPC
- Decision date
- 2018-11-16
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Updates to tooling equipment and part inspection test equipment and method.
Current openFDA PMA Record#
- Device
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S108
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2018-11-16
- Decision code
- OK30
- Date received
- 2018-10-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to tooling equipment and part inspection test equipment and method.