- Device
- WALLSTENT(R) ILIAC ENDOPROSTHESIS
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P940019
- Supplement
- S056
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2019-07-25
- Decision code
- OK30
- Date received
- 2019-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the current software with new software to collect and process manufacturing test data, and track and trend capability data for various manufacturing areas.