PMA P120003
- Device
- iCast Covered Stent System
- Applicant
- Atrium Medical Corp.
- Product code
- PRL
- Decision date
- 2026-05-13
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Approval for use of a new sterilization cycle with parametric release at the existing sterilizer
Current openFDA PMA Record#
- Device
- iCast Covered Stent System
- Applicant
- Atrium Medical Corp.
- PMA number
- P120003
- Supplement
- S007
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2026-05-13
- Decision code
- APPR
- Date received
- 2024-12-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for use of a new sterilization cycle with parametric release at the existing sterilizer