GORE HELEX SEPTAL OCCLUDER
FDA premarket approval P050006/S020 · decided 2011-10-13
Approval details
- PMA number
- P050006
- Supplement
- S020
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE HELEX SEPTAL OCCLUDER
- Generic name
- Transcatheter septal occluder
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2011-06-16
- Decision date
- 2011-10-13
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL TO MODIFY AN ACCEPTANCE CRITERION FOR THE CONTROL CATHETER COMPONENT.
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510(k) clearances by this applicant
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|---|---|---|
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
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| 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 |