LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator, LATITUDE NXT Syst
FDA premarket approval P910077/S180 · decided 2020-10-22
Approval details
- PMA number
- P910077
- Supplement
- S180
- 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, LATITUDE NXT Syst
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-08-06
- Decision date
- 2020-10-22
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for software changes included in LATITUDE NXT Patient Management System Release 7.0.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.