PMA P080012S036

Device: PROMETRA PATIENT THERAPY CONTROLLER
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S036
Product code: LKK
Decision date: 2017-03-31
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for a hardware change to the Patient Therapy Controller (Catalog No. 12860) that includes an updated Bluetooth Chip and removal of redundant circuitry in the battery protection circuit. This submission also requests an update to the device software (Version 1.02) to accommodate the change in hardware.

Current openFDA PMA Record#

Device: PROMETRA PATIENT THERAPY CONTROLLER
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S036
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2017-03-31
Decision code: APPR
Date received: 2016-09-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a hardware change to the Patient Therapy Controller (Catalog No. 12860) that includes an updated Bluetooth Chip and removal of redundant circuitry in the battery protection circuit. This submission also requests an update to the device software (Version 1.02) to accommodate the change in hardware.