SYNCHROMED II PROGRAMMABLE PUMP

FDA premarket approval P860004/S158 · decided 2011-12-09

Approval details

PMA number

P860004

Supplement

S158

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SYNCHROMED II PROGRAMMABLE PUMP

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2011-09-26

Decision date

2011-12-09

Days to decision

74 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE FOLLOWING: 1) THE ASSEMBLY PROCESS FOR THE ROLLER SUBCOMPONENT OF THE PUMPHEAD CURRENTLY USES A MANUAL PRESS AND WILL BE CHANGED TO USE A MOTORIZED PRESS THAT MONITORS AND CONTROLS TRAVEL DISTANCE AND ASSEMBLY FORCE. THIS CHANGE IS INTENDED TO IMPROVE YIELD AND MANUFACTURING EFFICIENCY; 2) THE MANUFACTURING TOLERANCE FOR THE NON-CRITICAL DIMENSION FOR THE PUMPHEAD ASSEMBLY DEFINED AS THE "STOP POSITION" WILL BE CHANGED FROM 10.77 + 0.044/-0.046 MILLIMETERS TO10.77 +/-0.060 MILLI

510(k) clearances by this applicant