Resolute Integrity Zotarolimus-Eluting Coronary Stent System RX and OTW
FDA premarket approval P110013/S116 · decided 2022-04-19
Approval details
- PMA number
- P110013
- Supplement
- S116
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Integrity Zotarolimus-Eluting Coronary Stent System RX and OTW
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2022-03-23
- Decision date
- 2022-04-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Transfer of component extrusion manufacturing operations.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.