GORE EXCLUDER AAA ENDOPROSTHESIS
FDA premarket approval P020004/S081 · decided 2013-05-02
Approval details
- PMA number
- P020004
- Supplement
- S081
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE EXCLUDER AAA ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2013-04-02
- Decision date
- 2013-05-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER.
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