RESOLUTE INTERGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM, RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM
FDA premarket approval P110013/S021 · decided 2013-12-12
Approval details
- PMA number
- P110013
- Supplement
- S021
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESOLUTE INTERGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM, RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-08-01
- Decision date
- 2013-12-12
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE C10 AND C19 POLYMERS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.