PMA P940019S061
- Device
- WALLSTENT™ ILIAC RP Endoprosthesis
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P940019
- Supplement
- S061
- Product code
- NIO
- Decision date
- 2022-11-22
- Generic name
- STENT, ILIAC
- Approval order statement
- Addition of an alternative heat seal coating to be used on the packaging.
Current openFDA PMA Record#
- Device
- WALLSTENT™ ILIAC RP Endoprosthesis
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P940019
- Supplement
- S061
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2022-11-22
- Decision code
- OK30
- Date received
- 2022-10-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative heat seal coating to be used on the packaging.