ENDURANT AND ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILAIAC (AUI) STENT GRAFT SYSTEM
FDA premarket approval P100021/S040 · decided 2014-10-03
Approval details
- PMA number
- P100021
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT AND ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILAIAC (AUI) STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2014-09-03
- Decision date
- 2014-10-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE SECONDARY AND TERTIARY PACKAGING FOR ENDURANT AND ENDURANT II STENT GRAFT SYSTEMS. ADDITIONALLY, A CHANGE IN CONFIGURATION FOR THE E-BEAM STERILIZATION PROCESS.
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