PMA P080007S025
- Device
- Bard E-Luminexx and LifeStar Vascular Stent
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S025
- Product code
- NIO
- Decision date
- 2021-08-05
- Generic name
- STENT, ILIAC
- Approval order statement
- Implement an alternative external process challenge device (ePCD) used in the sterilization process.
Current openFDA PMA Record#
- Device
- Bard E-Luminexx and LifeStar Vascular Stent
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S025
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2021-08-05
- Decision code
- OK30
- Date received
- 2021-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an alternative external process challenge device (ePCD) used in the sterilization process.