PMA P030009S086

Device: INTEGRITY CORONARY STENT SYSTEMS
Applicant: Medtronic, Ireland
PMA number: P030009
Supplement: S086
Product code: MAF
Decision date: 2016-12-09
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: Approval to reduce the number of tensile test samples taken at the beginning of each manufacturing, to upgrade the Hypotube Cutter machine and to change the control of the machine from pneumatic to automated.

Current openFDA PMA Record#

Device: INTEGRITY CORONARY STENT SYSTEMS
Applicant: Medtronic, Ireland
PMA number: P030009
Supplement: S086
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2016-12-09
Decision code: APPR
Date received: 2016-04-22
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to reduce the number of tensile test samples taken at the beginning of each manufacturing, to upgrade the Hypotube Cutter machine and to change the control of the machine from pneumatic to automated.