RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S067 · decided 2016-12-09
Approval details
- PMA number
- P110013
- Supplement
- S067
- Supplement type
- 135 Review Track For 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
- 2016-04-22
- Decision date
- 2016-12-09
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to reduce the number of tensile test samples taken at the beginning of each manufacturing, to upgrade the Hypotube Cutter machine and to change the control of the machine from pneumatic to automated.
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