FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Transcatheter Septal Occluder
PMA: P050006
·
Supplement: S101
·
Decision Oct 14, 2022
Classifications
1
FEI Numbers
11
Registration Numbers
11
Basic Information
- Device Name
- Transcatheter Septal Occluder
- Trade Name
- GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder
- PMA Number
- P050006
- Supplement Number
- S101
- Device Class
- FDA Class 3
- Product Code
- MLV
- Generic Name
- Transcatheter septal occluder
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 14, 2022
- Date Received
- July 20, 2022
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a modification to the formulation of coatings used in the handle of the delivery system.
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 |