PMA P080012S035

Device: PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S035
Product code: LKK
Decision date: 2016-08-31
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Inspection fixtures, inspection set-up, and manufacturing fixture changes used for verifying and assembling the Prometra and Prometra II pumps.

Current openFDA PMA Record#

Device: PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S035
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2016-08-31
Decision code: OK30
Date received: 2016-08-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Inspection fixtures, inspection set-up, and manufacturing fixture changes used for verifying and assembling the Prometra and Prometra II pumps.