NuDEL Delivery System
FDA premarket approval P150028/S005 · decided 2021-07-28
Approval details
- PMA number
- P150028
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NuDEL Delivery System
- Generic name
- Aortic stent
- Applicant
- NuMED, Inc.
- Date received
- 2021-04-28
- Decision date
- 2021-07-28
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hopkinton, NY
- Statement
- Approval to extend the packaging shelf life of the NuDEL Delivery System.
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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 |