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Device | DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 |
PMA Number | P120005 |
Supplement Number | S001 |
Date Received | 12/05/2012 |
Decision Date | 01/04/2013 |
Product Code |
MDS |
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 SEMI-AUTOMATE THE SUB-ASSEMBLY DISPOSABLE SEAL (DS) PROCESS USED IN THE G4 CONTINUOUS GLUCOSE MONITORING SYSTEM. ADDITIONALLY, A NEW CLEAN ROOM WAS ADDED TO ACCOMMODATE THE NEW DISPOSABLE SEAL MACHINE AND PROVIDE ADDITIONAL MANUFACTURING CAPACITY FOR THE OTHER PROCESSES. |