Resolute Onyx Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S008 · decided 2017-10-20
Approval details
- PMA number
- P160043
- Supplement
- S008
- 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
- 2017-10-05
- Decision date
- 2017-10-20
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Implement equivalent equipment used to print the stent size, description (DES), and 2 dimensional barcode information on the catheter luer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.