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 | S007 |
Date Received | 07/21/2015 |
Decision Date | 08/18/2015 |
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 CHANGE TO THE CURRENT BASE ASSEMBLY PROCESS USED FOR THE MANUFACTURE OF THEPUMP BASE OF THE ANIMAS VIBE SYSTEM TO IMPROVE OVERALL MANUFACTURING PROCESS EFFICIENCY. THE PROPOSED CHANGES INCLUDE REMOVAL OF REDUNDANT TEST STEPS, SEPARATION OF COMPLEX ASSEMBLYOPERATIONS INTO SEVERAL DISCRETE STEPS, AND THE ADDITION OF AN IDENTICAL ASSEMBLY STATION. |
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