PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012/S022 · decided 2014-12-18
Approval details
- PMA number
- P080012
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2014-06-30
- Decision date
- 2014-12-18
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR IMPLEMENTING A DESIGN CHANGE TO INCORPORATE A FLOW ACTUATED SAFETY VALVE (FAV) TO THE PROMETRA PUMP.
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