PMA P910001S125
- Device
- ELCA Coronary Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S125
- Product code
- LPC
- Decision date
- 2025-12-18
- Classification
- Cardiovascular
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- implementation of a new reduced EO sterilization cycle at an existing facility
Current openFDA PMA Record#
- Device
- ELCA Coronary Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S125
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2025-12-18
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a new reduced EO sterilization cycle at an existing facility