Prometra II Programmable Infusion Pump System
FDA premarket approval P080012/S057 · decided 2020-01-15
Approval details
- PMA number
- P080012
- Supplement
- S057
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prometra II Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2019-03-19
- Decision date
- 2020-01-15
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for change in the sourcing of the lubricant chemical and in the resin tint blends to not include a carrier for two syringes and a stop cock which are components in the Prometra II® Programmable Infusion Pump Accessories the Refill Kit and the Catheter Access Port Kit.
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