Resolute Integrity Coronary Stent Systems
FDA premarket approval P110013/S099 · decided 2019-08-12
Approval details
- PMA number
- P110013
- Supplement
- S099
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Integrity Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2019-08-09
- Decision date
- 2019-08-12
- Days to decision
- 3 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Implementation of a new dishwasher and water purification system in the shared glassware cleaning area within the Medtronic Ireland manufacturing facility.
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