ENDURANT STENT GRAFT SYSTEM
FDA premarket approval P100021/S018 · decided 2012-12-26
Approval details
- PMA number
- P100021
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2012-05-18
- Decision date
- 2012-12-26
- Days to decision
- 222 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MÉXICO EG IN EMPALME SONORA, MEXICO, FOR STENT GRAFT SEWING.
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