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UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS

FDA premarket approval P920023/S002 · decided 1996-09-27

Approval details

PMA number
P920023
Supplement
S002
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
Generic name
STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Applicant
Boston Scientific Corp
Date received
1996-09-09
Decision date
1996-09-27
Days to decision
18 days
Decision code
APPR
Product code
MER
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
APPROVAL TO INCREASE THE NUMBER OF INVESTIGATIONAL SITES FROM 7 TO 8 FOR THE "POST APPROVAL STUDY FOR THE UROLUME ENDOPROSTHESIS FOR TREATING RECURRENT BULBAR URETHRAL STRICTURE DISEASE

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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