MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT
FDA premarket approval P120010/S026 · decided 2015-02-04
Approval details
- PMA number
- P120010
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- 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.
- Date received
- 2014-06-23
- Decision date
- 2015-02-04
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR REPLACING THE TEST PLUG WITH TWO WATERTIGHT TESTERS IN THE MINILINK KIT.
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