PMA P110010S204

Device: Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S204
Product code: NIQ
Decision date: 2022-09-01
Generic name: Coronary drug-eluting stent
Approval order statement: Introducing automated equipment for packaging, sealing, and inspection of the inner pack for PROMUS products in the drug eluting stent production unit.

Current openFDA PMA Record#

Device: Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S204
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2022-09-01
Decision code: OK30
Date received: 2022-08-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introducing automated equipment for packaging, sealing, and inspection of the inner pack for PROMUS products in the drug eluting stent production unit.