FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Transcatheter Septal Occluder
PMA: P050006
·
Supplement: S118
·
Decision May 8, 2026
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
- PMA Number
- P050006
- Supplement Number
- S118
- 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
- May 8, 2026
- Date Received
- April 30, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to add an additional bake step to the delivery system component manufacturing process
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 |