Resolute Integrity Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P110013/S086 · decided 2018-04-18
Approval details
- PMA number
- P110013
- Supplement
- S086
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Resolute Integrity Zotarolimus-Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2017-11-22
- Decision date
- 2018-04-18
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to update the device labeling with the most currently available long-term clinical data from the Post-Approval Study.
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