Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
FDA premarket approval P150028/S001 · decided 2017-10-24
Approval details
- PMA number
- P150028
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
- Generic name
- Aortic stent
- Applicant
- NuMED, Inc.
- Date received
- 2017-02-17
- Decision date
- 2017-10-24
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hopkinton, NY
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIB Stent Placement Catheter (K213915) | NuMED, Inc. | 2022-01-12 |
| Z-6 Atrioseptostomy Catheter (K211910) | NuMED, Inc. | 2021-07-19 |
| BIB Stent Placement Catheter (K211134) | NuMED, Inc. | 2021-05-27 |
| D'Vill Introducer (K190974) | NuMED, Inc. | 2019-05-14 |
| D'Vill Introducer (K171206) | NuMED, Inc. | 2017-10-20 |
| BIB Stent Placement Catheter (K161451) | NuMED, Inc. | 2016-09-22 |
| REBOA Balloon Catheter (K160598) | NuMED, Inc. | 2016-06-20 |
| BIB Stent Placement Catheter (K160889) | NuMED, Inc. | 2016-05-20 |