PMA P160043S037
- Device
- Resolute Onyx Coronary Stent System
- Applicant
- Medtronic Vascular
- Product code
- NIQ
- Decision date
- 2020-10-05
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for a site change for packaging and labeling rework processes.
Current openFDA PMA Record#
- Device
- Resolute Onyx Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S037
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-10-05
- Decision code
- APPR
- Date received
- 2020-07-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a site change for packaging and labeling rework processes.