NIT-OCCLUD PDA
FDA premarket approval P120009/S004 · decided 2024-10-17
Approval details
- PMA number
- P120009
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- NIT-OCCLUD PDA
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- Pfm Medical, Inc.
- Date received
- 2023-01-12
- Decision date
- 2024-10-17
- Days to decision
- 644 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval for modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Nit-Occlud PDA PAS Study
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| JetCan® Pro Safety Huber Needle (K242763) | Pfm Medical, Inc. | 2025-05-02 |
| ASEPT® Glide Peritoneal Drainage System (K241278) | Pfm Medical, Inc. | 2025-01-14 |
| ASEPT Peritoneal Drainage System (K221779) | Pfm Medical, Inc. | 2023-05-02 |
| NuCath Wedge Pressure Catheter (K213666) | Pfm Medical, Inc. | 2022-10-06 |
| Asept Surgical Face Mask (K201137) | Pfm Medical, Inc. | 2020-08-19 |
| primeMidline Catheters (K192802) | Pfm Medical, Inc. | 2019-10-28 |
| primeMidline Catheters (K173114) | Pfm Medical, Inc. | 2018-03-07 |
| SAFETY BIOPSY NEEDLE SYSTEM (K140137) | Pfm Medical, Inc. | 2014-03-25 |