Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S039 · decided 2017-03-30
Approval details
- PMA number
- P080012
- Supplement
- S039
- Supplement type
- Special (Immediate Track)
- 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
- 2017-02-28
- Decision date
- 2017-03-30
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for MRI Conditional Labeling changes within the Instructions for Use, Patients Guide, Patient ID Cards which are associated with the Prometra Programmable Pump, Prometra II Programmable Pump, Intrathecal Catheter, and Catheter Revision Kit.
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