MEDTRONIC MODEL 8711 TWO PIECE INTRATHECAL CATHETER

FDA premarket approval P860004/S043 · decided 1999-10-29

Approval details

PMA number

P860004

Supplement

S043

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODEL 8711 TWO PIECE INTRATHECAL CATHETER

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

1999-10-18

Decision date

1999-10-29

Days to decision

11 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for a design change to the Model 8703W intraspinal catheter. The resulting catheter incorporates the same materials and basic design as Model 8703W except for a closed distal tip with six side holes instead of a single open tip. The device, as modified, will be marketed under the trade name Medtronic(R) Model 8711 Two Piece Intrathecal Catheter and is indicated for the containment and delivery of parenteral drugs to the intrathecal space of the spinal cord.

510(k) clearances by this applicant