Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S061 · decided 2019-11-08
Approval details
- PMA number
- P080012
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2019-08-13
- Decision date
- 2019-11-08
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for change to extend the shelf life of the Prometra II 20ml Pump component of the Prometra Programmable Infusion Pump System from 6 months to 1 year.
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