GORE EXCLUDER BIFURCATED ENDOPROSTHESIS
FDA premarket approval P020004/S007 · decided 2004-10-20
Approval details
- PMA number
- P020004
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- GORE EXCLUDER BIFURCATED ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2004-06-17
- Decision date
- 2004-10-20
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL FOR THE FORMAT TO BE USED FOR A CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIAN USERS AT LEAST ANNUALLY.
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