|
Device | EXCLUDER AAA ENDOPROSTHESIS SIM-PULL |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway Phoenix, AZ 85085 |
PMA Number | P020004 |
Supplement Number | S087 |
Date Received | 09/09/2013 |
Decision Date | 10/08/2013 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement DUPLICATION OF THE CURRENT COMBINED SIM-PULL AND C3 CATHETER MANUFACTURING PROCESS; ADDITION OF A NEW ISO 8 CLEANROOM AT AN ALREADY APPROVED FACILITY; AND MACHINERY ANDRECIPES UPGRADES AT BOTH APPROVED MANUFACTURING FACILITIES. |
Post-Approval Study | Show Report Schedule and Study Progress |