PMA P910001S119
- Device
- ECLA Coronary Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S119
- Product code
- LPC
- Decision date
- 2023-05-04
- Classification
- Cardiovascular
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Second supplier for the molded Proximal Coupler and Strain Relief components.
Current openFDA PMA Record#
- Device
- ECLA Coronary Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S119
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2023-05-04
- Decision code
- OK30
- Date received
- 2023-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second supplier for the molded Proximal Coupler and Strain Relief components.