PMA P110013S116
- Device
- Resolute Integrity Zotarolimus-Eluting Coronary Stent System – RX and OTW
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S116
- Product code
- NIQ
- Decision date
- 2022-04-19
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Transfer of component extrusion manufacturing operations.
Current openFDA PMA Record#
- Device
- Resolute Integrity Zotarolimus-Eluting Coronary Stent System – RX and OTW
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S116
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-04-19
- Decision code
- OK30
- Date received
- 2022-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of component extrusion manufacturing operations.