PMA P910001S113
- Device
- ELCA Coronary Atherectomy Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S113
- Product code
- LPC
- Decision date
- 2021-05-11
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for changing the devices labeling, specifically, the wording of a precaution statement in the Instructions for Use.
Current openFDA PMA Record#
- Device
- ELCA Coronary Atherectomy Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S113
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2021-05-11
- Decision code
- APPR
- Date received
- 2021-03-03
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changing the devices labeling, specifically, the wording of a precaution statement in the Instructions for Use.