PMA P920023S009
- Device
- UROLUME ENDOPROSTHESES
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S009
- Product code
- MES
- Decision date
- 1999-09-17
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- Approval for a new manufacturing site located at American Medical Systems, 10700 Bren Road West, Minnetonka, MN.
Current openFDA PMA Record#
- Device
- UROLUME ENDOPROSTHESES
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S009
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 1999-09-17
- Decision code
- APPR
- Date received
- 1999-08-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new manufacturing site located at American Medical Systems, 10700 Bren Road West, Minnetonka, MN.