PMA P910001S092
- Device
- ECLA GlideLight Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S092
- Product code
- LPC
- Decision date
- 2017-04-24
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval to add an additional in-process endotoxin test to the extruded components of the catheters.
Current openFDA PMA Record#
- Device
- ECLA GlideLight Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S092
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2017-04-24
- Decision code
- APPR
- Date received
- 2017-04-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add an additional in-process endotoxin test to the extruded components of the catheters.