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PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS ELITE Everolimus-Eluting Platinum Chro

FDA premarket approval P110010/S201 · decided 2022-08-18

Approval details

PMA number
P110010
Supplement
S201
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS ELITE Everolimus-Eluting Platinum Chro
Generic name
Coronary drug-eluting stent
Applicant
Boston Scientific Corp
Date received
2022-01-25
Decision date
2022-08-18
Days to decision
205 days
Decision code
APPR
Product code
NIQ
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for the optimization of the Promus BHT analytical chemistry method's sample preparation and gas chromatography instrument conditions.

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