SPECTRANETICS LASER SHEATH (SLSII)
FDA premarket approval P960042/S023 · decided 2011-11-18
Approval details
- PMA number
- P960042
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPECTRANETICS LASER SHEATH (SLSII)
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2010-11-22
- Decision date
- 2011-11-18
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT CARIDIANBCT STERILIZATION SERVICES IN LAKEWOOD, COLORADO.
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