ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787

FDA premarket approval P860004/S125 · decided 2012-05-02

Approval details

PMA number

P860004

Supplement

S125

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2010-04-19

Decision date

2012-05-02

Days to decision

744 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE SUBJECT ASCENDA CATHETER, WHICHCONSIST OF TWO MODELS (8780 AND 8781) (HAT ARE IDENTICAL IN COMPONENTS AND ACCESSORIES AND DIFFER ONLY IN THEIR TOTAL LENGTH. THIS CATHETER DIFFERS FROM THE CURRENT INTRATHECAL CATHETERS USED WITH MEDTRONIC IMPLANTABLE PUMPS BY THE FOLLOWING MODIFICATIONS: 1) MULTI-LAYERED CATHETER BODY THAT RESISTS CUTS, FRACTURES, AND OCCLUSIONS; 2) BI-WING ANCHOR WITH NEW ANCHOR DISPENSER DESIGNED TO PREVENT CATHETER DISLODGMENT; 3) CATHETER CONNECTOR THAT PREVE

510(k) clearances by this applicant