RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P110013/S012 · decided 2013-10-15
Approval details
- PMA number
- P110013
- Supplement
- S012
- 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
- 2013-04-26
- Decision date
- 2013-10-15
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A CHANGE TO THE EMPOWER SOFTWARE APPLICATION USED TO CONTROL THE ANALYTICAL CHROMATOGRAPHIC INSTRUMENTS FOR THE ANALYTICAL TESTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.