FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Transcatheter Septal Occluder
PMA: P050006
·
Supplement: S117
·
Decision Feb 20, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P050006 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Transcatheter Septal Occluder
- Trade Name
- GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal Occluder
- PMA Number
- P050006
- Supplement Number
- S117
- 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
- February 20, 2026
- Date Received
- February 6, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to update the inspection method for the guidewire slot feature for both the GORE® CARDIOFORM ASD Occluder and GORE® CARDIOFORM Septal Occluder
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 |