PMA P150028S001
- Device
- Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
- Applicant
- NuMED, Inc.
- PMA number
- P150028
- Supplement
- S001
- Product code
- PNF
- Decision date
- 2017-10-24
- Classification
- Aortic Stent
- Generic name
- Aortic stent
- Approval order statement
- Approval for the Covered CP Stent and Covered Mounted CP Stent Models. This device is indicated for use in the treatment of right ventricle to pulmonary artery (right ventricular outflow tract, RVOT) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR). In addition, approval for additional sizes (10-zig and lengths up to 60 mm for 8- and 10-zig configurations) for the Cheatham Platinum Stent System.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150028S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
- Applicant
- NuMED, Inc.
- PMA number
- P150028
- Supplement
- S001
- Product code
- PNF
- Generic name
- Aortic stent
- Decision date
- 2017-10-24
- Decision code
- APPR
- Date received
- 2017-02-17
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Covered CP Stent and Covered Mounted CP Stent Models. This device is indicated for use in the treatment of right ventricle to pulmonary artery (right ventricular outflow tract, RVOT) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR). In addition, approval for additional sizes (10-zig and lengths up to 60 mm for 8- and 10-zig configurations) for the Cheatham Platinum Stent System.