SYNCHROMED IMPLANTABLE INFUSION SYSTEM FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE)

FDA premarket approval P860004/S066 · decided 2005-02-14

Approval details

PMA number

P860004

Supplement

S066

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SYNCHROMED IMPLANTABLE INFUSION SYSTEM FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE)

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2005-01-21

Decision date

2005-02-14

Days to decision

24 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNCHROMED IMPLANTABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF PRESERVATIVE-FREE ZICONOTIDE STERILE SOLUTION FOR THE MANAGEMENT OF SEVERE, CHRONIC PAIN.

510(k) clearances by this applicant