|
Device | COOK CHORIONIC VILLUS SAMPLING SET |
Generic Name | Catheter, sampling, chorionic villus |
Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
PMA Number | P900007 |
Supplement Number | S004 |
Date Received | 04/01/2008 |
Decision Date | 05/08/2008 |
Product Code |
LLX |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE STERILIZATION AGENT USED IN PROCESSING THE COOK CHORIONIC VILLUS SAMPLING SET. |