THE AMPLATZER SEPTAL OCCLUDER DEVICE
FDA premarket approval P000039/S001 · decided 2002-03-27
Approval details
- PMA number
- P000039
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- THE AMPLATZER SEPTAL OCCLUDER DEVICE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2002-01-28
- Decision date
- 2002-03-27
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE.
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