COMPLETE SE VASCULAR STENT SYSTEM
FDA premarket approval P110040/S006 · decided 2015-07-09
Approval details
- PMA number
- P110040
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMPLETE SE VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular
- Date received
- 2015-03-20
- Decision date
- 2015-07-09
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
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