PMA P960042S070

Device: Glidelight Laser Sheath
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S070
Product code: MFA
Decision date: 2021-09-02
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Approval order statement: Approval for the Philips Laser System and for inclusion of the Philips Laser System as a compatible device within the labeling for the ELCA and Spectranetics Laser Sheath (SLS) and Glidelight Laser Sheath devices.

Current openFDA PMA Record#

Device: Glidelight Laser Sheath
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S070
Product code: MFA
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Decision date: 2021-09-02
Decision code: APPR
Date received: 2021-01-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Philips Laser System and for inclusion of the Philips Laser System as a compatible device within the labeling for the ELCA and Spectranetics Laser Sheath (SLS) and Glidelight Laser Sheath devices.