Atlas FDA

CARELINK PERSONAL SOFTWARE

FDA premarket approval P980022/S033 · decided 2008-09-24

Approval details

PMA number
P980022
Supplement
S033
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CARELINK PERSONAL SOFTWARE
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2008-08-18
Decision date
2008-09-24
Days to decision
37 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
APPROVAL FOR A CHANGE TO THE CARELINK PERSONAL THERAPYMANAGEMENT SOFTWARE FOR DIABETES (MMT-7333) THE CARELINK PERSONAL THERAPY MANAGEMENTSOFTWARE FOR DIABETES IS A NETWORK BASED SOFTWARE SYSTEM RESIDING ON A COMPUTER SERVER PLATFORM CONNECTED TO THE INTERNET. THE PURPOSE OF THIS SYSTEM IS TO TAKE INFORMATION TRANSMITTED FROM INSULIN PUMPS, CONTINUOUS GLUCOSE MONITORS AND GLUCOSE METERS, AND LOGBOOK DATA ENTERED BY THE PATIENT, AND TURN IT INTO MEDTRONIC CARELINK THERAPY MANAGEMENT SOFTWARE FOR

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
SmartGuard Technology; Predictive Low Glucose Technology (K261962)Medtronic MiniMed2026-07-09
SmartGuard Technology; Predictive Low Glucose Technology (K253701)Medtronic Minimed2026-02-03
MiniMed Go App (K253512)Medtronic Minimed2026-01-08
InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775)Medtronic Minimed2024-11-12
Extended Reservoir; MiniMed Reservoir (K241622)Medtronic Minimed2024-07-02
MiniMed Quick-serter (K160860)Medtronic Minimed2016-09-22
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206)Medtronic Minimed2012-03-29
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432)Medtronic Minimed2010-07-09