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Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C

FDA premarket approval P110010/S195 · decided 2022-10-14

Approval details

PMA number
P110010
Supplement
S195
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 and Promus Elite Everolimus-Eluting Platinum C
Generic name
Coronary drug-eluting stent
Applicant
Boston Scientific Corp
Date received
2021-06-09
Decision date
2022-10-14
Days to decision
492 days
Decision code
APPR
Product code
NIQ
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for reduction in the stent primer drying time for the PROMUS stent.

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510(k) clearances by this applicant

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
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WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21