ENDURANT AND ENDURANT II STENT GRAFT SYSTEM
FDA premarket approval P100021/S035 · decided 2014-05-13
Approval details
- PMA number
- P100021
- Supplement
- S035
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT AND ENDURANT II STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2014-04-15
- Decision date
- 2014-05-13
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR CLARIFICATIONS MADE TO THE REAR HANDLE ASSEMBLY MANUFACTURING PROCESS PROCEDURES.
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