Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
FDA premarket approval P160043/S031 · decided 2020-04-09
Approval details
- PMA number
- P160043
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2020-02-25
- Decision date
- 2020-04-09
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for introducing changes to the material of the desiccant (molecular sieve material) added to the product packaging post sterilization of the Resolute Onyx product.
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