PMA P030009S105

Device: Integrity Coronary Stent System RX and OTW
Applicant: Medtronic, Ireland
Product code: MAF
Decision date: 2021-12-14
Generic name: STENT, CORONARY
Approval order statement: Approval for changing the cleaning method for the extruder tooling used at the Santa Rosa site from a manual cleaning method to an automated cleaning method.

Current openFDA PMA Record#

Device: Integrity Coronary Stent System RX and OTW
Applicant: Medtronic, Ireland
PMA number: P030009
Supplement: S105
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2021-12-14
Decision code: APPR
Date received: 2021-06-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changing the cleaning method for the extruder tooling used at the Santa Rosa site from a manual cleaning method to an automated cleaning method.