FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Occluder, Patent Ductus, Arteriosus
PMA: P020024
·
Supplement: S066
·
Decision Jan 13, 2022
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Occluder, Patent Ductus, Arteriosus
- Trade Name
- Amplatzer Duct Occluder, Amplatzer Duct Occluder II
- PMA Number
- P020024
- Supplement Number
- S066
- Device Class
- FDA Class 3
- Product Code
- MAE
- Generic Name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 13, 2022
- Date Received
- November 22, 2021
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices.
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 |
|---|---|---|---|
| MAE | Occluder, Patent Ductus, Arteriosus | FDA class 3 | Unknown |