PMA P080012S075
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S075
- Product code
- LKK
- Decision date
- 2025-06-18
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval of the revised protocol for the post-approval study (Leachables Study).
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S075
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-06-18
- Decision code
- APPR
- Date received
- 2025-05-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (Leachables Study).