PMA P120003S003
- Device
- iCast Covered Stent System
- Applicant
- Atrium Medical Corp.
- PMA number
- P120003
- Supplement
- S003
- Product code
- PRL
- Decision date
- 2023-10-18
- Classification
- Cardiovascular
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- changes to the annealing of the Stainless Steel Tubing used to form the stent
Current openFDA PMA Record#
- Device
- iCast Covered Stent System
- Applicant
- Atrium Medical Corp.
- PMA number
- P120003
- Supplement
- S003
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2023-10-18
- Decision code
- OK30
- Date received
- 2023-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the annealing of the Stainless Steel Tubing used to form the stent