Glidelight Laser Sheath
FDA premarket approval P960042/S070 · decided 2021-09-02
Approval details
- PMA number
- P960042
- Supplement
- S070
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Glidelight Laser Sheath
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2021-01-25
- Decision date
- 2021-09-02
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- 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.
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