MINIMED 530G INSULIN PUMP
FDA premarket approval P120010/S005 · decided 2014-08-21
Approval details
- PMA number
- P120010
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MINIMED 530G INSULIN PUMP
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2013-11-08
- Decision date
- 2014-08-21
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF A PNEUMATIC PRESS TOOL IN PLACEOF A MANUAL PRESS TOOL IN THE MANUFACTURING PROCESS OF THE PARADIGM REAL-TIME INSULIN PUMP(MODELS:MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVELINSULIN-PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), GUARDIAN REALTIMEMONITOR (MODELS: CSS7100 AND CSS17100K) AND THE MINIMED 530G INSULIN PUMP(MODELS: MMT-551 AND MMT-751). THESE PARTS ARE COMPONENTS OF THE PARADIGM REAL-TIMESYSTEM, PARADIGM REAL-TIME REVEL SYSTEM
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