RESOLUTE INTEGRITY ZOTAROLIMUS_ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S049 · decided 2015-04-08
Approval details
- PMA number
- P110013
- Supplement
- S049
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESOLUTE INTEGRITY ZOTAROLIMUS_ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2014-12-18
- Decision date
- 2015-04-08
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE FOR BOTH THE RAPID EXCHANGE AND OVER-THE-WIRE DELIVERY SYSTEMS WITH THE LATEST AVAILABLE FOLLOW-UP CLINICAL DATA FROM THE VARIOUS STUDIES OF THE GLOBAL RESOLUTE CLINICAL TRIAL PROGRAM.
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