FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Occluder, Patent Ductus, Arteriosus
PMA: P020024
·
Supplement: S072
·
Decision Feb 12, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Occluder, Patent Ductus, Arteriosus
- Trade Name
- Amplatzer Piccolo Occluder
- PMA Number
- P020024
- Supplement Number
- S072
- 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
- February 12, 2026
- Date Received
- January 13, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to add an alternate laser welder to use in the manufacturing of the Amplatzer Amulet and Piccolo Occluders and to extend an existing laser cutter used for the Amulet to the Piccolo manufacturing process
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 |