RESOLUTE INTEGRITY RX & OTW ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S040 · decided 2014-05-23
Approval details
- PMA number
- P110013
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Trade name
- RESOLUTE INTEGRITY RX & OTW ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2014-04-25
- Decision date
- 2014-05-23
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE TO THE STENT SUB-ASSEMBLY MANUFACTURING EQUIPMENT.
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