RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM,RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM
FDA premarket approval P110013/S015 · decided 2013-11-07
Approval details
- PMA number
- P110013
- Supplement
- S015
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM,RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-06-10
- Decision date
- 2013-11-07
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR CHANGES TO THE COMPONENTS AND THE SOFTWARE OF THE DRUG SPRAY MACHINE.
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