THE AMPLATZER SEPTAL OCCLUDER
FDA premarket approval P000039/S015 · decided 2006-02-22
Approval details
- PMA number
- P000039
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THE AMPLATZER SEPTAL OCCLUDER
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-01-23
- Decision date
- 2006-02-22
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO ADDRESS REPORTED ADVERSE EVENTS SUCH AS TISSUE EROSION/PERFORATION AND DEVICE EMBOLIZATION.
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