ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

FDA premarket approval P120010/S082 · decided 2016-01-27

Approval details

PMA number

P120010

Supplement

S082

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Generic name

Automated insulin dosing , threshold suspend

Applicant

Medtronic, Inc.

Date received

2015-12-28

Decision date

2016-01-27

Days to decision

30 days

Decision code

OK30

Product code

OZO

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

THE APPROVAL OF A TRANSITION OF THE MANUFACTURING OF THE TYVEK LIDS USED FOR PACKAGING THE ENLITE SENSOR COMPONENT FROM THE SUPPLIER'S FACILITY IN PHILADELPHIA TO OSHKOSH, WISCONSIN. ADDITIONALLY, THE FACILITY TRANSITION INCLUDES NEW MANUFACTURING ASSETS INCLUDING COATER AND DIE CUT LID PRESS. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEMS.

510(k) clearances by this applicant