GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM
FDA premarket approval P020004/S078 · decided 2012-12-21
Approval details
- PMA number
- P020004
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2012-11-21
- Decision date
- 2012-12-21
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- CHANGE TO THE PARAMETERS FOR BONDING THE OLIVE TO THE CATHETER SHAFT.
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