AMPLATZER DUCT OCCLUDER
FDA premarket approval P020024/S024 · decided 2010-12-23
Approval details
- PMA number
- P020024
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AMPLATZER DUCT OCCLUDER
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-03-06
- Decision date
- 2010-12-23
- Days to decision
- 657 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR UPDATES TO THE LABELING OF THE AMPLATZER DUCT OCCLUDER TO REFLECT THE FINDINGS OF THE POST APPROVAL STUDY.
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