SLS SPECTRANETICS LASER SHEATHS
FDA premarket approval P960042/S036 · decided 2012-05-24
Approval details
- PMA number
- P960042
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SLS SPECTRANETICS LASER SHEATHS
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2012-04-05
- Decision date
- 2012-05-24
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A MODIFICATION TO THE FISH TAPE ACCESSORY OF THE DEVICE.
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