RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S009 · decided 2013-04-12
Approval details
- PMA number
- P110013
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Trade name
- RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-03-14
- Decision date
- 2013-04-12
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AN UPDATE TO THE PRODUCT LABELING TO ADD THE ACRONYM 'BMS' TO THE INTEGRITY PRODUCT AND 'DES' TO THE RESOLUTE INTEGRITY PRODUCT TO THE DEVICE'S LUER.
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