PMA P110013S115
- Device
- Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S115
- Product code
- NIQ
- Decision date
- 2021-11-16
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site.
Current openFDA PMA Record#
- Device
- Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S115
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-11-16
- Decision code
- OK30
- Date received
- 2021-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site.