RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P110013/S052 · decided 2015-06-26
Approval details
- PMA number
- P110013
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2015-05-27
- Decision date
- 2015-06-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- UPDATE TO THE VISUAL STANDARDS USED IN THE INSPECTION OF THE FINAL POUCH SEALING.
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