EXCLUDER BIFURCATED ENDOPROSTHESIS
FDA premarket approval P020004/S130 · decided 2016-05-05
Approval details
- PMA number
- P020004
- Supplement
- S130
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXCLUDER BIFURCATED ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2016-04-08
- Decision date
- 2016-05-05
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Use of PTFE and PTFE/FEP fibers made by an approved supplier in the manufacture of the EXCLUDER AAA Endoprosthesis and Iliac Branch Endoprosthesis.
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| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |