COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA
FDA premarket approval P110040/S005 · decided 2014-04-03
Approval details
- PMA number
- P110040
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular
- Date received
- 2014-03-04
- Decision date
- 2014-04-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- IMPLEMENTATION OF NEW COATING EQUIPMENT AND PROCESS CONTROLS.
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