RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P110013/S016 · decided 2013-09-12
Approval details
- PMA number
- P110013
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Trade name
- RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-06-17
- Decision date
- 2013-09-12
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A REVISED ELUTION SPECIFICATION.
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