PMA P920023S020
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S020
- Product code
- MES
- Decision date
- 2007-04-17
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- ADDITIONAL IN-PROCESS CYTOTOXICITY TESTING SITE FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S020
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2007-04-17
- Decision code
- OK30
- Date received
- 2007-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL IN-PROCESS CYTOTOXICITY TESTING SITE FOR THE DEVICE.