PMA supplement
P120010 S026: MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT
FDA PMA supplement · Real-Time Process · Medtronic, Inc.
Key facts
| Original PMA | P120010 |
|---|---|
| Supplement number | S026 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT |
| Generic name | Automated insulin dosing , threshold suspend |
| Applicant | Medtronic, Inc. |
| Product code | OZO |
| Received date | Jun 23, 2014 |
| Decision date | Feb 4, 2015 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: