ENDURANT,ENDURANT II AND ENDURANT II AOTYO-UNI-LIAC (AUI) STENT GRAFT SYSTEM
FDA premarket approval P100021/S054 · decided 2017-01-13
Approval details
- PMA number
- P100021
- Supplement
- S054
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT,ENDURANT II AND ENDURANT II AOTYO-UNI-LIAC (AUI) STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2016-06-28
- Decision date
- 2017-01-13
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for implementation of use of disassembled finished devices in the quarterly dose audit process.
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