|
Device | GAMBRO PRISMAFLEX TPE 2000 SET |
Generic Name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
Applicant | BAXTER INTERNATIONAL, INC. 1 BAXTER PKWY. DEERFIELD, IL 60015-4633 |
PMA Number | P830063 |
Supplement Number | S007 |
Date Received | 05/29/2015 |
Decision Date | 06/26/2015 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE PYROGEN TEST METHOD (FROM RABBIT TEST TO KINETIC-CHROMOGENIC LAL TEST) USED FOR PRODUCT RELEASE OF PRISMAFLEX TPE 2000 SETS. |