FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Occluder, Patent Ductus, Arteriosus
PMA: P000039
·
Supplement: S053
·
Decision Feb 24, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Occluder, Patent Ductus, Arteriosus
- Trade Name
- AMPLATZER SEPTAL OCCLUDER
- PMA Number
- P000039
- Supplement Number
- S053
- 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
- February 24, 2016
- Date Received
- October 30, 2015
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for a manufacturing site located at Sterigenics, in Willowbrook, Illinois.
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 |