ELCA and SLS/GlideLight Catheter
FDA premarket approval P960042/S056 · decided 2017-04-24
Approval details
- PMA number
- P960042
- Supplement
- S056
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELCA and SLS/GlideLight Catheter
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2017-04-07
- Decision date
- 2017-04-24
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval to add an additional in-process endotoxin test to the extruded components of the catheters.
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