LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM
FDA premarket approval P910077/S140 · decided 2014-06-20
Approval details
- PMA number
- P910077
- Supplement
- S140
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-11-20
- Decision date
- 2014-06-20
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LATITUDE NXT 2.0 SOFTWARE FOR THE WAVE COMMUNICATOR MODEL 6460, CHANGES TO THE WAVE COMMUNICATOR 6280, APPROVAL OF THE WAVE COMMUNICATOR 6290, AND UPDATES TO THE COMMUNICATION SOFTWARE FOR WAVE COMMUNICATOR MODELS 6498 AND6476.
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