PMA P910001S122
- Device
- ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS)
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S122
- Product code
- LPC
- Decision date
- 2024-09-05
- Classification
- Cardiovascular
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- implementation of manufacturing software
Current openFDA PMA Record#
- Device
- ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS)
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S122
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2024-09-05
- Decision code
- OK30
- Date received
- 2024-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing software