AMPLATZER DUCT OCCLUDER (ADO)
FDA premarket approval P020024/S038 · decided 2014-10-29
Approval details
- PMA number
- P020024
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMPLATZER DUCT OCCLUDER (ADO)
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2013-02-06
- Decision date
- 2014-10-29
- Days to decision
- 630 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR CONVERTING THE NITINOL WIRE USED IN THE MANUFACTURE OF THESE DEVICES FROM A BLACK OXIDE SURFACE FINISH TO A CHEMICALLY ETCHED SURFACE FINISH.
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|---|---|---|
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