PMA P910001S116
- Device
- ELCA Coronoary Laser Atherectomy Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S116
- Product code
- LPC
- Decision date
- 2022-08-19
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for implementing new catheter bonding materials.
Current openFDA PMA Record#
- Device
- ELCA Coronoary Laser Atherectomy Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S116
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2022-08-19
- Decision code
- APPR
- Date received
- 2022-06-17
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementing new catheter bonding materials.