MINIMED 530G INSULIN PUMP

FDA premarket approval P120010/S008 · decided 2014-03-13

Approval details

PMA number

P120010

Supplement

S008

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MINIMED 530G INSULIN PUMP

Generic name

Automated insulin dosing , threshold suspend

Applicant

Medtronic, Inc.

Date received

2013-12-23

Decision date

2014-03-13

Days to decision

80 days

Decision code

APPR

Product code

OZO

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

APPROVAL FOR CHANGES TO THE STACK ASSEMBLIES AND BATTERY TUBE ASSEMBLY TO COMPLY WITH ROHS (RESTRICTION OF HAZARDOUS SUBSTANCES) REQUIREMENTS. THESE CHANGES INCLUDE CHANGES TO FIVE COMPONENTS ON THE STACK ASSEMBLY, A CHANGE IN MATERIAL FOR THE BARE PRINTED CIRCUIT BOARDS (PCBS) OF THE STACK ASSEMBLY AND BATTERY TUBE ASSEMBLY, AND A CHANGE TO THE SOLDER MATERIAL (FROM TIN/LEAD TO TIN/SILVER/COPPER) USED ON THE PCBS.

510(k) clearances by this applicant