SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT)
FDA premarket approval P960042/S049 · decided 2014-10-09
Approval details
- PMA number
- P960042
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT)
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2014-07-14
- Decision date
- 2014-10-09
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.
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