PMA P920023S021
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S021
- Product code
- MES
- Decision date
- 2007-07-27
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S021
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2007-07-27
- Decision code
- OK30
- Date received
- 2007-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.