Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | PRISMAFLEX TPE2000 |
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 | S014 |
Date Received | 11/15/2019 |
Decision Date | 12/11/2019 |
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 Addition of an anti-error tubing connector feature to the support plate of the Prismaflex TPE2000 Set and a move of the manufacturing of several set components (e.g., striped tubes, luer components, and injection sites) to Marsa, Malta from Medolla, Italy. |
|
|