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 | ANIMAS VIBE SYSTEM |
Generic Name | Pump, infusion, insulin, to be used with invasive glucose sensor |
Applicant | ANIMAS CORP. 965 CHESTERBROOK BLVD. WAYNE, PA 19087 |
PMA Number | P130007 |
Supplement Number | S014 |
Date Received | 04/21/2016 |
Decision Date | 07/06/2016 |
Withdrawal Date
|
06/11/2020 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the solder composition for three subassemblies used in the Animas Vibe pump as required for RoHS compliance. The Animas Vibe pump is a component of the Animas Vibe System. |
|
|