Resolute Integrity Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P110013/S091 · decided 2018-12-20
Approval details
- PMA number
- P110013
- Supplement
- S091
- 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
- 2018-09-17
- Decision date
- 2018-12-20
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to reduce the duration of follow-up from 5 years to 3 years.
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