PMA P080012S031
- Device
- PROMETRA PROGRAMMABLE PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S031
- Product code
- LKK
- Decision date
- 2015-12-28
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: A REVISION TO ALLOW FOR THE USE OF THE APPROVED PATIENT THERAPY CONTROLLER OR PTC IN THE POST-APPROVAL CLINICAL STUDY FOR THE PROMETRA IMPLANTABLE PROGRAMMABLE PUMP SYSTEM.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S031
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2015-12-28
- Decision code
- APPR
- Date received
- 2015-10-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: A REVISION TO ALLOW FOR THE USE OF THE APPROVED PATIENT THERAPY CONTROLLER OR PTC IN THE POST-APPROVAL CLINICAL STUDY FOR THE PROMETRA IMPLANTABLE PROGRAMMABLE PUMP SYSTEM.