MEDTRONIC SYNCHROMED INFUSION SYSTEM

FDA premarket approval P860004/S040 · decided 1998-04-13

Approval details

PMA number

P860004

Supplement

S040

Supplement type

Normal 180 Day Track

Trade name

MEDTRONIC SYNCHROMED INFUSION SYSTEM

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

1998-01-15

Decision date

1998-04-13

Days to decision

88 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

Approval to modify the prescription caution statement on the SynchroMed prouduct labeling from "Caution: Federal law restricts this device to sale, distribution, and use by or on the order of a physician," to that specified in 21 CFR 801.109(b)(1), "Caution: Federal law restricts this device to sale by or on the order of a physician". FDA also acknowledges and approves the substitution of "(USA)" for "Federal law" for devices distributed outside of the United States.

510(k) clearances by this applicant