MINIMED 530G INSULIN PUMP

FDA premarket approval P120010/S039 · decided 2014-11-26

Approval details

PMA number

P120010

Supplement

S039

Supplement type

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

2014-10-27

Decision date

2014-11-26

Days to decision

30 days

Decision code

OK30

Product code

OZO

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

CHANGE FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS FOR A TEST CARRIEDOUT DURING ACCEPTANCE TESTING OF THE PARADIGM® REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K); PARADIGM® REAL-TIME REVEL INSULIN PUMP (MODELS:MMT-523, MMT-523K, MMT-723, MMT-723K); MINIMED 530G INSULIN PUMP (MODELS:MMT-551, MMT-751) CASES. THE PARADIGM® REAL-TIME, PARADIGM® REAL-TIME REVEL, ANDMINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM® REAL-TIME SYSTEM,PARADIGM® REAL-TIME REVEL SYSTEM

510(k) clearances by this applicant