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 | Pump, infusion, insulin, to be used with invasive glucose sensor |
Applicant | ANIMAS CORP. 965 CHESTERBROOK BLVD. WAYNE, PA 19087 |
PMA Number | P130007 |
Supplement Number | S031 |
Date Received | 09/29/2017 |
Decision Date | 10/24/2017 |
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 Supplier change for the manufacturing of a molded component of the key pad assembled into the Animas Vibe Insulin pump which is part of the Animas Vibe System. The Animas Vibe System consists of the Animas Vibe Insulin Pump paired with the Dexcom G4 PLATINUM Sensor and Transmitter. |
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