RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S002 · decided 2012-12-21
Approval details
- PMA number
- P110013
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2012-05-10
- Decision date
- 2012-12-21
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE INTRODUCTION OF A STENT ALIGNMENT MANUFACTURING PROCESS AND A MARKER BAND SPACING SPECIFICATION CHANGE.
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