PROMETRA PATIENT THERAPY CONTROLLER
FDA premarket approval P080012/S036 · decided 2017-03-31
Approval details
- PMA number
- P080012
- Supplement
- S036
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROMETRA PATIENT THERAPY CONTROLLER
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2016-09-16
- Decision date
- 2017-03-31
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for a hardware change to the Patient Therapy Controller (Catalog No. 12860) that includes an updated Bluetooth Chip and removal of redundant circuitry in the battery protection circuit. This submission also requests an update to the device software (Version 1.02) to accommodate the change in hardware.
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