Resolute Onyx Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S038 · decided 2020-09-25
Approval details
- PMA number
- P160043
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2020-08-27
- Decision date
- 2020-09-25
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.