RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM
FDA premarket approval P110013/S024 · decided 2014-02-05
Approval details
- PMA number
- P110013
- Supplement
- S024
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-08-09
- Decision date
- 2014-02-05
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE RESIDUAL SOLVENTS ANALYTICAL TEST METHOD USED FOR THE TESTING OF THE C10 AND C19 POLYMERS, WHICH ARE A COMPONENT OF THE STENT COATING.
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