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 | S009 |
Date Received | 09/21/2015 |
Decision Date | 10/21/2015 |
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 TRANSFERRING THE GLUCOSE ENGINE RADIO FREQUENCY BOARD ASSEMBLY (GE ASSEMBLY) SCREENING TESTING TO THE SUPPLIER. THE GE ASSEMBLY IS A COMPONENT OF THE ANIMAS VIBE SYSTEM. |
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