SYNCHROMED IMPLANTABLE INFUSION PUMP SYSTEM

FDA premarket approval P860004/S046 · decided 2001-06-29

Approval details

PMA number

P860004

Supplement

S046

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SYNCHROMED IMPLANTABLE INFUSION PUMP SYSTEM

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2001-06-18

Decision date

2001-06-29

Days to decision

11 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THREE NEW PUMP CONNECTOR DESIGNS AND A CHANGE IN THE MODEL 8709 CATHETER KIT CONTENTS: 1) NEW MODEL 8575 400 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER. 2) NEW MODEL 8577 900 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER. 3) NEW MODEL 8576 900 PUMP CONNECTOR FOR USE WITH THE MODEL 8700A AND MODEL 8700V VASCULAR CATHETERS. 4) NEW MODEL 8709 CATHETER KITS WILL REPLACE THE CURRENT CATHETERS WITH THE 400 MODEL 8575 PUMP CONNECTOR FOR SYNCHROMED PUMPS WITH A CAP (CAT

510(k) clearances by this applicant