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SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER

FDA premarket approval P840040/S050 · decided 1995-10-19

Approval details

PMA number
P840040
Supplement
S050
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Boston Scientific Corp
Date received
1995-09-06
Decision date
1995-10-19
Days to decision
43 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR REVISED LABELING TO ADDRESS OUR PTCA LABELING LETTER OF JAN 7, 1995 AND CHANGE THE CORPORATE NAME ON YOUR LABELING FROM MANSFIELD/BOSTON SCIENTIFIC CORP TO SCIMED/BOSTON SCIENTIFIC CORP

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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