PMA P960042S073
- Device
- GlideLight Laser Sheath
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S073
- Product code
- MFA
- Decision date
- 2025-12-18
- Classification
- Cardiovascular
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- implementation of a new reduced EO sterilization cycle at an existing facility
Current openFDA PMA Record#
- Device
- GlideLight Laser Sheath
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S073
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2025-12-18
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a new reduced EO sterilization cycle at an existing facility