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UROLUME(TM)ENDOPROSTHESIS

FDA premarket approval P920023/S004 · decided 1998-07-15

Approval details

PMA number
P920023
Supplement
S004
Supplement type
Normal 180 Day Track
Supplement reason
Postapproval Study Protocol
Trade name
UROLUME(TM)ENDOPROSTHESIS
Generic name
STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Applicant
Boston Scientific Corp
Date received
1998-06-22
Decision date
1998-07-15
Days to decision
23 days
Decision code
APPR
Product code
MER
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Approval to: 1)increase the number or investigational sites in the post-approval study of new patients (post-approval study#2) under the recurrent bulbar urethral strictures application, and 2) increase the patient enrollment limit to 132 (to include 57 original and 75 new patients) for the post-approval study of the BPH application.

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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