INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR

FDA premarket approval P860004/S167 · decided 2012-02-17

Approval details

PMA number

P860004

Supplement

S167

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2011-12-27

Decision date

2012-02-17

Days to decision

52 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE SUTURELESS CONNECTOR (SC) CATHETER MODELS 8709SC AND 8731SC, AND REVISION KIT MODELS 8578 AND 8596SC TO ADDRESS THE POTENTIAL FOR SIDE LOAD LEAKS. THE MODIFICATION TO YOUR SUTURELESS CONNECTOR ARE AS FOLLOWS: 1) DECREASED THE COUNTER BORE DIAMETER FROM 0.040" TO 0.035"; 2) DECREASED THE DEPTH OF THE COUNTER BORE FROM 0.055" TO 0.050"; 3) INCREASED THE TOLERANCE FOR THE 0.15" DIMENSION OF THE TUBING POSITION FROM +-0.01 TO +-0.02; AND 4) ADDED A REQUIREMENT TO THE PRODUCT SPECIFI

510(k) clearances by this applicant