ENDURANT STENT GRAFT SYSTEM,ENDURANT II STENT GRAFT SYSTEM,ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM
FDA premarket approval P100021/S026 · decided 2013-06-25
Approval details
- PMA number
- P100021
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT STENT GRAFT SYSTEM,ENDURANT II STENT GRAFT SYSTEM,ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2013-05-28
- Decision date
- 2013-06-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE TO THE WATER SOLUBLE ADDITIVE THAT IS USED DURING THE LASER CUTTINGPROCESS.
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