ENDURANT STENT GRAFT SYSTEM
FDA premarket approval P100021/S010 · decided 2011-09-16
Approval details
- PMA number
- P100021
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ENDURANT STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2011-08-18
- Decision date
- 2011-09-16
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR MINOR LABELING CHANGES TO UPDATE CAUTION STATEMENTS.
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