Resolute Integrity Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P110013/S097 · decided 2019-12-18
Approval details
- PMA number
- P110013
- Supplement
- S097
- 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
- 2019-06-21
- Decision date
- 2019-12-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for changes to the directions for use to include the most currently available long-term clinical follow-up data for the Resolute Integrity US Xl Sub-study.
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