PARADIGM REAL TIME SYSTEM
FDA premarket approval P980022/S013 · decided 2006-04-07
Approval details
- PMA number
- P980022
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADIGM REAL TIME SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2005-10-04
- Decision date
- 2006-04-07
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MMT 515/715 EXTERNAL INSULIN PUMP AND TO THE GUARDIAN RT SENSOR TO ENABLE THE PUMP TO ACCEPT DATA FROM THE SENSOR, AND TO ENABLE THE SENSOR TO COMMUNICATE DIRECTLY TO THE PUMP. THE DEVICE WILL BE MANUFACTURED AT MEDTRONIC MINIMED, NORTHRIDGE, CALIFORNIA.
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| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206) | Medtronic Minimed | 2012-03-29 |
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