PMA P920023S015
- Device
- UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S015
- Product code
- MES
- Decision date
- 2004-07-22
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- APPROVAL TO CONCLUDE THE BENIGN PROSTATIC HYPERTROPHY PORTION OF THE UROLUME POST-APPROVAL STUDY AND TO INCLUDE THE PROBABILITY OF EXPLANT DUE TO TISSUE RESPONSE AT 10 YEARS IN THE LABELING.
Current openFDA PMA Record#
- Device
- UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S015
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2004-07-22
- Decision code
- APPR
- Date received
- 2002-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL TO CONCLUDE THE BENIGN PROSTATIC HYPERTROPHY PORTION OF THE UROLUME POST-APPROVAL STUDY AND TO INCLUDE THE PROBABILITY OF EXPLANT DUE TO TISSUE RESPONSE AT 10 YEARS IN THE LABELING.