PMA P080012S043

Device: Prometra Programmable Infusion Pump System
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S043
Product code: LKK
Decision date: 2017-06-07
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Alternate supplier (Hudson Technologies Company, One Blue Hill Plaza, Pearl River, New York) of R-21(dichlorofluoromethane) for the Prometra Programmable Infusion Pump System.

Current openFDA PMA Record#

Device: Prometra Programmable Infusion Pump System
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S043
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2017-06-07
Decision code: OK30
Date received: 2017-05-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate supplier (Hudson Technologies Company, One Blue Hill Plaza, Pearl River, New York) of R-21(dichlorofluoromethane) for the Prometra Programmable Infusion Pump System.