FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Occluder, Patent Ductus, Arteriosus
PMA: P000039
·
Supplement: S003
·
Decision Jan 15, 2003
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Occluder, Patent Ductus, Arteriosus
- Trade Name
- AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS
- PMA Number
- P000039
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- MAE
- Generic Name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 15, 2003
- Date Received
- December 16, 2002
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE IN THE MANUFACTURING PROCESS TO OBTAIN AN ALTERNATE SUPPLIER FOR COMPONENTS USED WITH THE AMPLATZER SEPTAL OCCLUDER AND DELIVERY EXCHANGE SYSTEMS.
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 |