|
Device | ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | COOK, INC. 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
PMA Number | P020018 |
Supplement Number | S017 |
Date Received | 10/04/2006 |
Decision Date | 10/25/2006 |
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 ALLOWING THE INTERNAL AND EXTERNAL THREADS OF THE DILATOR TIP (A COMPONENT OF THE H&L-B ONE-SHOT INTRODUCTION SYSTEM) TO BE MACHINED BY AN OUTSIDE VENDOR. |