Integrity Coronary Stent System
FDA premarket approval P030009/S104 · decided 2022-01-27
Approval details
- PMA number
- P030009
- Supplement
- S104
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Integrity Coronary Stent System
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2021-05-17
- Decision date
- 2022-01-27
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- 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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