MINILINK REAL-TIME TRANSMITTER
FDA premarket approval P120010/S023 · decided 2014-10-02
Approval details
- PMA number
- P120010
- Supplement
- S023
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MINILINK REAL-TIME TRANSMITTER
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-04-29
- Decision date
- 2014-10-02
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A CHANGE TO REPLACE THE CURRENT HOLDER (BLUE TEST PLUG)USED AS A PRODUCTION AID DURING SUB-ASSEMBLY MANUFACTURING OF THE MINILINK (MMT-7703) ANDIPRO2 (MMT-7741) TRANSMITTERS TO TWO NEW HOLDERS. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINKREAL-TIME AND MINIMED 530G SYSTEMS. THE IPRO2 TRANSMITTER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.
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510(k) clearances by this applicant
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