Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S049 · decided 2019-06-18
Approval details
- PMA number
- P080012
- Supplement
- S049
- 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
- 2017-12-26
- Decision date
- 2019-06-18
- Days to decision
- 539 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for the addition of REF16827, a 40mL drug capacity pump with Access Port Spacer component to be used at the Clinician's discretion; software modifications to revision 2.01.3 of the system's Clinician Programmer REF13828 and REF12828 and revision 2.01.1 of the systems Patient Therapy Controller (PTC) REF12860; and labeling updates made to reflect the above changes and differentiate the 40mL pump from the 20mL pump.
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