Endurant, EndurantII, Endurant lls Stent Graft Systems
FDA premarket approval P100021/S065 · decided 2017-08-10
Approval details
- PMA number
- P100021
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endurant, EndurantII, Endurant lls Stent Graft Systems
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2017-07-14
- Decision date
- 2017-08-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Group the Endurant, Endurant II and Endurant IIs Stent Graft System; and the Valiant Thoracic Stent Graft System with Captivia Delivery System; for routine bacterial endotoxin testing (BET).
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