PMA P110013S108
- Device
- Resolute Integrity zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S108
- Product code
- NIQ
- Decision date
- 2021-03-12
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Implementation of new product label and component verification software for use on manufacturing lines in Medtronic Ireland.
Current openFDA PMA Record#
- Device
- Resolute Integrity zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S108
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-03-12
- Decision code
- OK30
- Date received
- 2021-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new product label and component verification software for use on manufacturing lines in Medtronic Ireland.