PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012/S024 · decided 2015-02-12
Approval details
- PMA number
- P080012
- Supplement
- S024
- 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
- 2014-11-17
- Decision date
- 2015-02-12
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR IMPLEMENTING A MIXED LOAD STERILIZATION CONFIGURATION FOR THE PROMETRA PUMPS ACCESSORY KITS, WHICH ARE ETHYLENE OXIDE STERILIZED.
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