OPTIhome Remote Patient Monitoring System
FDA premarket approval P180036/S024 · decided 2023-12-01
Approval details
- PMA number
- P180036
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIhome Remote Patient Monitoring System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2023-09-05
- Decision date
- 2023-12-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- approval for changes to the OPTIhome Remote Patient Monitoring System software for the OPTIMIZER Smart Mini 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.