PMA P910001S102
- Device
- CVX-300 Excimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S102
- Product code
- LPC
- Decision date
- 2017-12-22
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Use of an alternate Joulemeter for laser-light measurement during production.
Current openFDA PMA Record#
- Device
- CVX-300 Excimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S102
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2017-12-22
- Decision code
- OK30
- Date received
- 2017-11-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternate Joulemeter for laser-light measurement during production.