MMT-7335 CARELINK PRO PC SOFTWARE
FDA premarket approval P980022/S052 · decided 2009-05-22
Approval details
- PMA number
- P980022
- Supplement
- S052
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MMT-7335 CARELINK PRO PC SOFTWARE
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2009-03-25
- Decision date
- 2009-05-22
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE CARELINK PRO PC SOFTWARE (VERSION 1.3A, MMT-7335) TO CORRECT TWO IDENTIFIED PROBLEMS.
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