PMA P150003S017

Device: SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P150003
Supplement: S017
Product code: NIQ
Decision date: 2016-08-18
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: Update to the software used on the Automated Catheter Manufacturing Line Distal and Port Load and Unload stations in Galway.

Current openFDA PMA Record#

Device: SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P150003
Supplement: S017
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2016-08-18
Decision code: OK30
Date received: 2016-07-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update to the software used on the Automated Catheter Manufacturing Line Distal and Port Load and Unload stations in Galway.