Stent Graft Drying Process at Medtronic Empalme And Medtronic Tijuana Endurant, Endurant II, Endurant II Aorto-Uni-lliac
FDA premarket approval P100021/S064 · decided 2017-05-19
Approval details
- PMA number
- P100021
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Stent Graft Drying Process at Medtronic Empalme And Medtronic Tijuana Endurant, Endurant II, Endurant II Aorto-Uni-lliac
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2017-04-19
- Decision date
- 2017-05-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Use of an additional, new drying oven for stent graft processing.
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