PMA P170030S060

Device: Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System
Applicant: Biotronik AG
PMA number: P170030
Supplement: S060
Product code: NIQ
Decision date: 2026-02-22
Classification: Cardiovascular
Generic name: Coronary drug-eluting stent
Approval order statement: sample size reduction of in process inspections for the crimped and embedded stent diameters during final assembly

Current openFDA PMA Record#

Device: Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System
Applicant: Biotronik AG
PMA number: P170030
Supplement: S060
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2026-02-22
Decision code: OK30
Date received: 2026-01-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: sample size reduction of in process inspections for the crimped and embedded stent diameters during final assembly