PMA P860004S056

Device: SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S056
Product code: LKK
Decision date: 2003-09-12
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR THE MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM WHICH INCLUDES MODEL 8637 SYNCHROMED II PROGRAMMABLE PUMP, SYNCHROMED II APPLICATION SOFTWAARE ON THE MODEL 8870 APPLICATION CARD, MODEL 8551 REFILL KIT, MODEL 8540 CATHETER ACCESS PORT KIT, AND MODEL 8590-1 POUCH KIT.

Current openFDA PMA Record#

Device: SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S056
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2003-09-12
Decision code: APPR
Date received: 2003-04-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM WHICH INCLUDES MODEL 8637 SYNCHROMED II PROGRAMMABLE PUMP, SYNCHROMED II APPLICATION SOFTWAARE ON THE MODEL 8870 APPLICATION CARD, MODEL 8551 REFILL KIT, MODEL 8540 CATHETER ACCESS PORT KIT, AND MODEL 8590-1 POUCH KIT.