SPECTRANETICS LASER SHEATH (SLS)
FDA premarket approval P960042/S012 · decided 2009-11-05
Approval details
- PMA number
- P960042
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPECTRANETICS LASER SHEATH (SLS)
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2009-04-01
- Decision date
- 2009-11-05
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, LLC, SALT LAKE CITY, UTAH FOR STERILIZATION PACKAGING.
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