MEDTRONIC SYNCHROMED INFUSION

FDA premarket approval P860004/S081 · decided 2006-03-22

Approval details

PMA number

P860004

Supplement

S081

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC SYNCHROMED INFUSION

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2006-01-13

Decision date

2006-03-22

Days to decision

68 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDING A SUTURELESS PUMP CONNECTOR TO BOTH MODELS 8709 AND 8731 CATHETERS COMPATIBLE WITH THE SYNCHROMED AND ISOMED IMPLANTABLE INFUSION PUMPS; 2) ADDING NUMBERS (IN CENTIMETERS) TO THE MARKINGS ON THE 8709 CATHETER BODY LIKE THOSE ON THE 8731 CATHETER; 3) ADDING A SHORTER (9.3 CM) INTRODUCER NEEDLE TO THE MODEL 8731 KIT; 4) ADDING CONNECTOR PINS AND STRAIN RELIEF SLEEVES TO MODEL 8731 CATHETER KIT ALLOWING THE PUMP SEGMENT OF THE CATHETER TO BE TRIMMED; 5)

510(k) clearances by this applicant