- Device
- SLS II/GlideLight catheters
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S062
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2018-06-28
- Decision code
- APPR
- Date received
- 2018-06-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional visual inspection on the marker band on the distal tip of the SLS GlideLight laser lead extraction catheters.