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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceMiniMed 630G Pump
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150001
Supplement NumberS033
Date Received01/23/2018
Decision Date02/22/2018
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the addition of 100% visual inspection to the manufacturing protocol for P-cap O-rings (Part Number D5022027-001) and addition of a second de-flashing procedure to remove excess flash in out-of-spec (OOS) O-rings having flash >0.003.
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