PMA P080012S028
- Device
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S028
- Product code
- LKK
- Decision date
- 2015-07-31
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S028
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2015-07-31
- Decision code
- APPR
- Date received
- 2015-05-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.