VASCULAR CATHETER

FDA premarket approval P860004/S050 · decided 2002-05-02

Approval details

PMA number

P860004

Supplement

S050

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VASCULAR CATHETER

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2002-04-23

Decision date

2002-05-02

Days to decision

9 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR CATHETER MODEL 8708 IN WHICH THE STRAIGHT CONNECTOR IS REPLACED WITH RIGHT ANGLE CONNECTOR, THE NUMBER OF ANCHOR BEADS IS INCREASED TO 12. ALSO, REMOVAL OF ACCESSORY COMPONENTS SPECIFIED AS GUIDE WIRE, TUNNELING ACCESSORIES AND TWO PRE-ATTACHED ANCHORS FROM MODEL 8700A, 8700V AND 8702 PACKAGE. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER THE TRADE NAME MEDTRONIC VASCULAR CATHETER MODEL 8708 AND IS INDICATED FOR USE WITH THE MEDTRONIC IMPLANTABLE INFUSION PUMPS TO PROVIDE FLUID PATH

510(k) clearances by this applicant