RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S047 · decided 2014-12-10
Approval details
- PMA number
- P110013
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2014-11-10
- Decision date
- 2014-12-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- OPTION TO STERILIZE USING CYCLE #3 ON LINES 9 AND 3, CHANGING THE RESOLUTE INTEGRITY¿S PALLET CONFIGURATION, AND CO-STERILIZATION OF ALL SIMILAR DES DEVICES (INCLUDING THOSE COMMERCIALIZED OUTSIDE OF US).
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