Atlas FDA

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

FDA premarket approval P110010/S210 · decided 2023-04-10

Approval details

PMA number
P110010
Supplement
S210
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Promus Premier Everolimus-Eluting Platinum C
Generic name
Coronary drug-eluting stent
Applicant
Boston Scientific Corp
Date received
2023-03-28
Decision date
2023-04-10
Days to decision
13 days
Decision code
OK30
Product code
NIQ
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Additional manufacturing line to increase production of a piece that protects the final finished device during shipping and handling prior to use.

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

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
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
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