FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Sensor, Glucose, Invasive
PMA: P160007
·
Supplement: S053
·
Decision Aug 25, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- Guardian Connect system
- PMA Number
- P160007
- Supplement Number
- S053
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 25, 2025
- Date Received
- August 15, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to update the inspection requirements performed by Medtronic Tempe Campus (MTC) on a component used in the glucose sensor Printed Circuit Board Assembly (PCBA). The PCBA is a component of the Minimed 670G system, Guardian connect system, and Simplera sync sensor, guardian 4 sensor
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |