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BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER

FDA premarket approval P880065/S006 · decided 2001-07-30

Approval details

PMA number
P880065
Supplement
S006
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER
Generic name
PULSE-GENERATOR, PROGRAM MODULE
Applicant
Boston Scientific Corp
Date received
2001-07-12
Decision date
2001-07-30
Days to decision
18 days
Decision code
APPR
Product code
LOT
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.

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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