AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM
FDA premarket approval P000039/S023 · decided 2007-12-04
Approval details
- PMA number
- P000039
- Supplement
- S023
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-07-10
- Decision date
- 2007-12-04
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR AGA MEDICAL CORPORATION TO BECOME THE PRIMARY SOURCE FOR THE LASER WELDING PROCESS, WHILE RETAINING THE CURRENT VENDOR AS A SECONDARY SOURCE.
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