PMA P120003S009
- Device
- iCast Covered Stent System
- Applicant
- Atrium Medical Corp.
- PMA number
- P120003
- Supplement
- S009
- Product code
- PRL
- Decision date
- 2025-12-22
- Classification
- Cardiovascular
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- approval to add new implant sizes to the design matrix (10mm x 59mm stent, 32mm stent length, and 12mm stent diameter)
Current openFDA PMA Record#
- Device
- iCast Covered Stent System
- Applicant
- Atrium Medical Corp.
- PMA number
- P120003
- Supplement
- S009
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2025-12-22
- Decision code
- APPR
- Date received
- 2025-06-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval to add new implant sizes to the design matrix (10mm x 59mm stent, 32mm stent length, and 12mm stent diameter)