PMA P160007S063

Device
Simplera System; Simplera Sync
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S063
Product code
MDS
Decision date
2026-07-21
Classification
Clinical Chemistry
Generic name
Sensor, glucose, invasive
Approval order statement
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Current openFDA PMA Record#

Device
Simplera System; Simplera Sync
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S063
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2026-07-21
Decision code
OK30
Date received
2026-06-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
undefined