Talent Occluder With Occluder Delivery System
FDA premarket approval P100021/S093 · decided 2022-01-27
Approval details
- PMA number
- P100021
- Supplement
- S093
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Talent Occluder With Occluder Delivery System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2021-05-17
- Decision date
- 2022-01-27
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for using calculations of spore log resistance to evaluate lethality challenges of the requalification microbiological performance qualification for process development.
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