PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012/S023 · decided 2015-07-29
Approval details
- PMA number
- P080012
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- 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
- 2014-09-15
- Decision date
- 2015-07-29
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR THE PATIENT THERAPY CONTROLLER AND CONFIGURATION DEVICE FOR USE WITH THE PROMETRA PROGRAMMABLE INFUSION SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.