PMA P920023S027
- Device
- AMSUROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S027
- Product code
- MES
- Decision date
- 2010-09-30
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- CHANGE IN A MEASUREMENT METHOD USED DURING RECEIVING/ INSPECTION.
Current openFDA PMA Record
- Device
- AMSUROLUME ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- P920023
- Supplement
- S027
- Product code
- MES
- Generic name
- STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2010-09-30
- Decision code
- OK30
- Date received
- 2010-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN A MEASUREMENT METHOD USED DURING RECEIVING/ INSPECTION.