PMA P920023S010
- Device
- UROLUME(R) ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S010
- Product code
- MES
- Decision date
- 2000-02-14
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- Extend the shelf life expiration dating up to 5 years.
Current openFDA PMA Record
- Device
- UROLUME(R) ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S010
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2000-02-14
- Decision code
- APPR
- Date received
- 1999-09-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Extend the shelf life expiration dating up to 5 years.