SLS / GlideLight
FDA premarket approval P960042/S058 · decided 2017-07-18
Approval details
- PMA number
- P960042
- Supplement
- S058
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SLS / GlideLight
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2017-06-30
- Decision date
- 2017-07-18
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for modifications to inspection practices for the primary packaging of the affected devices.
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