LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT Syste
FDA premarket approval P910077/S168 · decided 2019-02-22
Approval details
- PMA number
- P910077
- Supplement
- S168
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT Syste
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-12-03
- Decision date
- 2019-02-22
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for changes to the Server and Communicator software updates necessary for LATITUDE NXT Release 6.1.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.