PMA P920023S019
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S019
- Product code
- MES
- Decision date
- 2006-12-05
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- ADD A SECOND IN-PROCESS CYTOTOXICITY TESTING SITE.
Current openFDA PMA Record#
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S019
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2006-12-05
- Decision code
- OK30
- Date received
- 2006-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A SECOND IN-PROCESS CYTOTOXICITY TESTING SITE.