| 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 | Guardian Connect System |
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| Generic Name | Sensor, glucose, invasive |
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| Applicant | Medtronic Minimed
18000 Devonshire St.
Northridge, CA 91325 |
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| PMA Number | P160007 |
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| Supplement Number | S037 |
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| Date Received | 08/04/2020 |
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| Decision Date | 09/02/2020 |
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| Product Code |
MDS |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT02246582
|
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| Supplement Type | 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
IntriCon Corporation (IntriCon Red Fox), 1260 Red Fox Road, Saint Paul, MN as an alternative finished product manufacturing facility and IntriCon Corporation Grey Fox (IntriCon Grey Fox), 1275 Grey Fox Road Arden Hills, MN as an alternate final packaging process facility for the Guardian Link (3) and Guardian Connect Transmitter. The transmitters are components of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The submission also requested approval of process changes related to the new manufacturing facilities including a new inspection process and equipment. |
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