PMA P960042S069
- Device
- SLS/GlideLight
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S069
- Product code
- MFA
- Decision date
- 2020-05-06
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- Change in supplier of extruded outer jacket and inner extension tubing components.
Current openFDA PMA Record#
- Device
- SLS/GlideLight
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S069
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2020-05-06
- Decision code
- OK30
- Date received
- 2020-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier of extruded outer jacket and inner extension tubing components.