- Device
- Integrity Coronary Stent System
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S104
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2022-01-27
- Decision code
- APPR
- Date received
- 2021-05-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for using calculations of spore log resistance to evaluate lethality challenges of the requalification microbiological performance qualification for process development.