PMA P920023S024
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S024
- Product code
- MES
- Decision date
- 2008-05-30
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
Current openFDA PMA Record#
- Device
- UROLUME URETHRAL STENT
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S024
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2008-05-30
- Decision code
- OK30
- Date received
- 2008-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.