RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P110013/S075 · decided 2017-02-01
Approval details
- PMA number
- P110013
- Supplement
- S075
- 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 SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2016-08-17
- Decision date
- 2017-02-01
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for updated in-process sampling requirements and to remove redundant inspections.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.