PMA P080012S039

Device: Prometra Programmable Infusion Pump System
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S039
Product code: LKK
Decision date: 2017-03-30
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for MRI Conditional Labeling changes within the Instructions for Use, Patients Guide, Patient ID Cards which are associated with the Prometra Programmable Pump, Prometra II Programmable Pump, Intrathecal Catheter, and Catheter Revision Kit.

Current openFDA PMA Record#

Device: Prometra Programmable Infusion Pump System
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S039
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2017-03-30
Decision code: APPR
Date received: 2017-02-28
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for MRI Conditional Labeling changes within the Instructions for Use, Patients Guide, Patient ID Cards which are associated with the Prometra Programmable Pump, Prometra II Programmable Pump, Intrathecal Catheter, and Catheter Revision Kit.