PMA P080012S047

Device: Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S047
Product code: LKK
Decision date: 2017-12-19
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for modifications of product labeling as a result of MRI testing conducted on the Flowonix Prometra Programmable Infusion Pump System.

Current openFDA PMA Record#

Device: Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S047
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2017-12-19
Decision code: APPR
Date received: 2017-09-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications of product labeling as a result of MRI testing conducted on the Flowonix Prometra Programmable Infusion Pump System.