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. |
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Device | ANIMAS VIBE SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | ANIMAS CORP. 965 CHESTERBROOK BLVD. WAYNE, PA 19087 |
PMA Number | P130007 |
Supplement Number | S010 |
Date Received | 02/05/2016 |
Decision Date | 03/02/2016 |
Withdrawal Date
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06/11/2020 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change in the current Animas Vibe Insulin Pump final QC/kitting process required to implement process improvements to eliminate an unnecessary parts reconciliation process, eliminate process redundancy, and to improve overall manufacturing process efficiency. The Animas Vibe Insulin Pump is a component of the Animas Vibe System. |
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