PMA P920023S004

Device: UROLUME(TM)ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S004
Product code: MER
Decision date: 1998-07-15
Generic name: STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Approval order 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.

Current openFDA PMA Record

Device: UROLUME(TM)ENDOPROSTHESIS
Applicant: Boston Scientific Corp
PMA number: P920023
Supplement: S004
Product code: MER
Generic name: STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
Decision date: 1998-07-15
Decision code: APPR
Date received: 1998-06-22
Supplement type: Normal 180 Day Track
Supplement reason: Postapproval Study Protocol
Approval order 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.