Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S064 · decided 2020-01-15
Approval details
- PMA number
- P080012
- Supplement
- S064
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2019-12-27
- Decision date
- 2020-01-15
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for minor software changes (correction of firmware errors) to bring the Prometra II Programmable Pumps (20mL and 40mL) back into specification to match the performance as reflected in the original software requirements.
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