MEDTRONIC SYNCHROMED IMPLANTABLE INFUSION PUMP

FDA premarket approval P860004/S042 · decided 1999-03-18

Approval details

PMA number

P860004

Supplement

S042

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC SYNCHROMED IMPLANTABLE INFUSION PUMP

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

1999-02-26

Decision date

1999-03-18

Days to decision

20 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for addition of an alternate catheter port for use with the SynchroMed pump, Model 8508 CAP; Addition of an Application Specific Integrated Circuit (ASIC) buffer chip to the pumps hybrid to improve battery longevity; addition of another suture loop to the shield; change in the device name from SynchroMed(TM) to SynchroMed EL(TM); change in model numbers (new model numbers represent new SynchroMed EL Pumps); and change to labeling.

510(k) clearances by this applicant