AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
FDA premarket approval P020024 · decided 2003-05-14
Approval details
- PMA number
- P020024
- Trade name
- AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2002-06-24
- Decision date
- 2003-05-14
- Days to decision
- 324 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM. THE PERCUTANEOUS, TRANSCATHETER OCCLUSION DEVICE IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSUS (PDA).
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