GORE CARDIOFORM SEPTAL OCCLUDER
FDA premarket approval P050006/S044 · decided 2015-04-30
Approval details
- PMA number
- P050006
- Supplement
- S044
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE CARDIOFORM SEPTAL OCCLUDER
- Generic name
- Transcatheter septal occluder
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2014-11-03
- Decision date
- 2015-04-30
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL FOR ADDITION OF THE GORE CARDIOFORM SEPTAL OCCLUDER TO THE GORE HELEX SEPTAL OCCLUDER LINE.
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| 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 |