PMA P920023S029
- Device
- AMS UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S029
- Product code
- MES
- Decision date
- 2010-12-02
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- MANUFACTURING PROCEDURE CHANGE PERTAINING TO AN IN-PROCESS TEST OF THE DELIVERY TOOL.
Current openFDA PMA Record#
- Device
- AMS UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S029
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2010-12-02
- Decision code
- OK30
- Date received
- 2010-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING PROCEDURE CHANGE PERTAINING TO AN IN-PROCESS TEST OF THE DELIVERY TOOL.