PMA P170030S051

Device: Orsiro Mission Sirolimus Eluting Coronary Stent System
Applicant: Biotronik AG
PMA number: P170030
Supplement: S051
Product code: NIQ
Decision date: 2025-04-11
Classification: Cardiovascular
Generic name: Coronary drug-eluting stent
Approval order statement: the introduction of an additional wire position control and movability check during the guidewire exit port (GEP) welding and cutting manufacturing steps for the PK Papyrus Covered Coronary Stent System and the Orsiro Mission Sirolimus Eluting Coronary Stent System

Current openFDA PMA Record#

Device: Orsiro Mission Sirolimus Eluting Coronary Stent System
Applicant: Biotronik AG
PMA number: P170030
Supplement: S051
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2025-04-11
Decision code: APPR
Date received: 2025-01-28
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the introduction of an additional wire position control and movability check during the guidewire exit port (GEP) welding and cutting manufacturing steps for the PK Papyrus Covered Coronary Stent System and the Orsiro Mission Sirolimus Eluting Coronary Stent System