PMA P080012S050

Device: Prometra Programmable Infusion Pump System
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S050
Product code: LKK
Decision date: 2019-01-31
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for the addition of baclofen (baclofen injection, intrathecal, 500-2000 microgram/mL) to the Prometra Programmable Infusion Pump System indications for use and corresponding labeling changes to the device system.

Current openFDA PMA Record#

Device: Prometra Programmable Infusion Pump System
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S050
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2019-01-31
Decision code: APPR
Date received: 2018-02-06
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of baclofen (baclofen injection, intrathecal, 500-2000 microgram/mL) to the Prometra Programmable Infusion Pump System indications for use and corresponding labeling changes to the device system.