PMA P030009S098

Device: Integrity Rapid Exchange Coronary Stent System
Applicant: Medtronic, Ireland
PMA number: P030009
Supplement: S098
Product code: MAF
Decision date: 2020-10-30
Generic name: STENT, CORONARY
Approval order statement: Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.

Current openFDA PMA Record#

Device: Integrity Rapid Exchange Coronary Stent System
Applicant: Medtronic, Ireland
PMA number: P030009
Supplement: S098
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2020-10-30
Decision code: OK30
Date received: 2020-10-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.