PMA P030047S019
- Device
- PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S019
- Product code
- NIM
- Decision date
- 2011-02-14
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.
Current openFDA PMA Record#
- Device
- PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S019
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2011-02-14
- Decision code
- APPR
- Date received
- 2010-02-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.