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EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD

FDA premarket approval P010012/S391 · decided 2015-07-16

Approval details

PMA number
P010012
Supplement
S391
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD
Applicant
Boston Scientific Corp
Date received
2015-06-22
Decision date
2015-07-16
Days to decision
24 days
Decision code
OK30
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.

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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
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