GORE EXCLUDER AAA ENDOPROSTHESIS
FDA premarket approval P020004/S028 · decided 2008-04-11
Approval details
- PMA number
- P020004
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE EXCLUDER AAA ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2007-09-12
- Decision date
- 2008-04-11
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.
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