FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Transcatheter Septal Occluder
PMA: P050006
·
Supplement: S116
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Transcatheter Septal Occluder
- Trade Name
- GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder
- PMA Number
- P050006
- Supplement Number
- S116
- Device Class
- FDA Class 3
- Product Code
- MLV
- Generic Name
- Transcatheter septal occluder
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 19, 2025
- Date Received
- December 2, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
adding an alternative sub-tier supplier for the marker band component of the delivery catheter assemblies for the GORE CARDIOFORM Septal Occluder (GSO Device) and the GORE CARDIOFORM ASD Occluder (GCA Device)
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MLV | Transcatheter Septal Occluder | FDA class 3 | Unknown |