Resolute Onyx Over-the-Wire (OTW) Zotarolimus Eluting Coronary Stent System
FDA premarket approval P160043/S023 · decided 2019-04-26
Approval details
- PMA number
- P160043
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Over-the-Wire (OTW) Zotarolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2019-03-28
- Decision date
- 2019-04-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- the addition of an alternate manufacturing site for the Resolute Onyx OTW catheter subassembly
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