PMA P110010S200

Device: Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S200
Product code: NIQ
Decision date: 2022-02-10
Generic name: Coronary drug-eluting stent
Approval order statement: Addition of an alternative contract testing laboratory to carry out confirmatory testing on Everolimus for the SYNERGY and PROMUS devices.

Current openFDA PMA Record#

Device: Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S200
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2022-02-10
Decision code: OK30
Date received: 2022-01-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternative contract testing laboratory to carry out confirmatory testing on Everolimus for the SYNERGY and PROMUS devices.