MEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP

FDA premarket approval P860004/S022 · decided 1996-07-29

Approval details

PMA number

P860004

Supplement

S022

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

1991-09-13

Decision date

1996-07-29

Days to decision

1781 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR (1) THE 10 CC SYNCHROMED IMPLANTABLE PROGRAMMABLE INFUSION PUMP, MODELS 8616-10 AND 8617-10 FOR USE IN THE PEDIATRIC AND ADULT POPULATION FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION( FOR THE MANAGEMENT OF SEVERE SPASTICITY OF SPINAL AND CEREBRAL ORIGIN, AND (2) TO CHANGE THE INDICATIONS FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION) FOR THE 18 CC RESERVOIR SYNCHROMED IMPLANTABLE, PROGRAMMABLE INFUSION PUMPS, MODELS 8616-18, 861

510(k) clearances by this applicant