CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42
FDA premarket approval P150028/S007 · decided 2026-07-06
Approval details
- PMA number
- P150028
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42
- Generic name
- Aortic stent
- Applicant
- NuMED, Inc.
- Date received
- 2025-07-21
- Decision date
- 2026-07-06
- Days to decision
- 350 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hopkinton, NY
- Statement
- approval for a manufacturing site located at Sterigenics U.S., LLC, 84 Park Road, Queensbury, NY 12804 as a contract sterilization facility, and modifications to reduce the ethylene oxide concentration at the existing contract sterilization facility at Cosmed Group (Lynx Medical) at 2205 East 33rd Street, Erie, PA, 16510
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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 |