Valiant Thoracic Stent Graft with the Captivia Delivery System
FDA premarket approval P100040/S034 · decided 2018-02-01
Approval details
- PMA number
- P100040
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2018-01-03
- Decision date
- 2018-02-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Relocation of stent graft manufacturing operations at a Medtronic manufacturing facility.
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