Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S069 · decided 2021-03-02
Approval details
- PMA number
- P080012
- Supplement
- S069
- 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
- 2020-12-01
- Decision date
- 2021-03-02
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for a minor software changes to address three minor issues with the Patient Therapy controller REF 12860.
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