PMA P940019S054
- Device
- Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P940019
- Supplement
- S054
- Product code
- NIO
- Decision date
- 2019-04-17
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Add an existing EO sterilization cycle to an additional chamber in order to increase cycle capacity.
Current openFDA PMA Record#
- Device
- Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P940019
- Supplement
- S054
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2019-04-17
- Decision code
- OK30
- Date received
- 2019-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an existing EO sterilization cycle to an additional chamber in order to increase cycle capacity.