Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S067 · decided 2020-10-29
Approval details
- PMA number
- P080012
- Supplement
- S067
- Supplement type
- Real-Time Process
- 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
- 2020-07-31
- Decision date
- 2020-10-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for change to implement a software update of the Clinician Programmer Application Software (2.01.6) to improve Bluetooth connection reliability in Clinician Programmer REF 13828.
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