PMA P960042S066
- Device
- Spectranetics Laser Sheath (SLS) II and GlideLight Laser Sheath
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S066
- Product code
- MFA
- Decision date
- 2019-06-28
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- Add an alternate supplier for the bifurcate subcomponent and update the respective inspection equipment.
Current openFDA PMA Record#
- Device
- Spectranetics Laser Sheath (SLS) II and GlideLight Laser Sheath
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S066
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2019-06-28
- Decision code
- OK30
- Date received
- 2019-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the bifurcate subcomponent and update the respective inspection equipment.