PMA P960042S056
- Device
- ELCA and SLS/GlideLight Catheter
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S056
- Product code
- MFA
- Decision date
- 2017-04-24
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- Approval to add an additional in-process endotoxin test to the extruded components of the catheters.
Current openFDA PMA Record#
- Device
- ELCA and SLS/GlideLight Catheter
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S056
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- 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.