|
Device | GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N |
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 | S002 |
Date Received | 01/18/2000 |
Decision Date | 08/28/2002 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE REQUIREMENTS OF THE POST-MARKET STUDY FOR THE DEVICE. |
Post-Approval Study | Show Report Schedule and Study Progress |