GORE CADIOFORM Septal Occluder
FDA premarket approval P050006/S061 · decided 2017-09-27
Approval details
- PMA number
- P050006
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE CADIOFORM Septal Occluder
- Generic name
- Transcatheter septal occluder
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2017-08-29
- Decision date
- 2017-09-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |