PMA P020036S055
- Device
- S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S055
- Product code
- NIO
- Decision date
- 2025-05-28
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- approval for updates to the labeling including instructions for use, implant card, and packaging labels.
Current openFDA PMA Record#
- Device
- S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S055
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-05-28
- Decision code
- APPR
- Date received
- 2025-04-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for updates to the labeling including instructions for use, implant card, and packaging labels.