PMA P160043S040
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S040
- Product code
- NIQ
- Decision date
- 2020-12-21
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- introduction of a robotic aid for the packaging and labeling workstep
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S040
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-12-21
- Decision code
- OK30
- Date received
- 2020-12-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of a robotic aid for the packaging and labeling workstep