PMA P920023S031
- Device
- Ams Urolume Endoprosthesis
- Applicant
- Boston Scientific Corp.
- PMA number
- P920023
- Supplement
- S031
- Decision date
- 2012-08-02
Current openFDA PMA Record
- Device
- AMS UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S031
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2012-08-02
- Decision code
- OK30
- Date received
- 2012-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM.