SLS ll/GlideLight Catheters
FDA premarket approval P960042/S063 · decided 2018-08-14
Approval details
- PMA number
- P960042
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SLS ll/GlideLight Catheters
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2018-07-16
- Decision date
- 2018-08-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Addition of a vent hood to the main manufacturing clean room wicking stations.
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