GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS
FDA premarket approval P020004/S133 · decided 2016-07-11
Approval details
- PMA number
- P020004
- Supplement
- S133
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2016-06-17
- Decision date
- 2016-07-11
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Implementation of circumferential tensile testing as a lot acceptance test for the graft component of the GORE EXCLUDER Iliac Branch Endoprosthesis.
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