Resolute Onyx RX and OTW Coronary Stent Systems
FDA premarket approval P160043/S003 · decided 2017-07-19
Approval details
- PMA number
- P160043
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx RX and OTW Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2017-06-19
- Decision date
- 2017-07-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Introduce changes to the work steps used in the manufacture of the bare metal stent, collectively titled the "Lean Cell (LC) manufacturing process".
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