PMA P910001S104
- Device
- CVX-300 Excimer Laser System/ELCA Coronary Atherectomy Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S104
- Product code
- LPC
- Decision date
- 2018-05-08
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Reduction of routine monitoring of the purified water system.
Current openFDA PMA Record#
- Device
- CVX-300 Excimer Laser System/ELCA Coronary Atherectomy Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S104
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2018-05-08
- Decision code
- OK30
- Date received
- 2018-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction of routine monitoring of the purified water system.