|
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 | S008 |
Date Received | 10/13/2015 |
Decision Date | 11/12/2015 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO ADDRESS COMPLAINTS RELATED TO LUER CONNECTOR CRACKS. |