PMA P920023S030
- Device
- AMS UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S030
- Product code
- MES
- Decision date
- 2011-12-14
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- CHANGE IN A MEASUREMENT METHOD USED DURING THE POST STERILE PACKAGING OPERATION.
Current openFDA PMA Record#
- Device
- AMS UROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S030
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2011-12-14
- Decision code
- OK30
- Date received
- 2011-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN A MEASUREMENT METHOD USED DURING THE POST STERILE PACKAGING OPERATION.