GORE HELEX SEPTAL OCCLUDER
FDA premarket approval P050006/S002 · decided 2006-12-13
Approval details
- PMA number
- P050006
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- GORE HELEX SEPTAL OCCLUDER
- Generic name
- Transcatheter septal occluder
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2006-10-16
- Decision date
- 2006-12-13
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
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| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
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| 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 |