PMA P890055S057

Device: CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP ACCESSORIES, MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S057
Product code: LKK
Decision date: 2014-07-11
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS BELGIUM (PETIT-RECHAIN) S.A. IN VERVIERS, BELGIUM.

Current openFDA PMA Record#

Device: CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP ACCESSORIES, MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S057
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2014-07-11
Decision code: APPR
Date received: 2014-06-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS BELGIUM (PETIT-RECHAIN) S.A. IN VERVIERS, BELGIUM.