PMA P910001S114
- Device
- ELCA Coronary Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S114
- Product code
- LPC
- Decision date
- 2022-02-24
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for changes being effected (CBE) for Philips Laser System manufacturing verification processes.
Current openFDA PMA Record#
- Device
- ELCA Coronary Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S114
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2022-02-24
- Decision code
- APPR
- Date received
- 2022-02-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes being effected (CBE) for Philips Laser System manufacturing verification processes.