AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
FDA premarket approval P020024/S006 · decided 2006-02-06
Approval details
- PMA number
- P020024
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-10-13
- Decision date
- 2006-02-06
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE END SCREW DESIGN.
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