PMA P910001S095
- Device
- ELCA Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S095
- Product code
- LPC
- Decision date
- 2017-08-22
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for adding in-process visual inspections for the Distal Marker Band on the Excimer Laser Coronary Atherectomy (ELCA) catheters.
Current openFDA PMA Record#
- Device
- ELCA Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S095
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2017-08-22
- Decision code
- APPR
- Date received
- 2017-07-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for adding in-process visual inspections for the Distal Marker Band on the Excimer Laser Coronary Atherectomy (ELCA) catheters.