LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0
FDA premarket approval P910077/S143 · decided 2014-07-16
Approval details
- PMA number
- P910077
- Supplement
- S143
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-05-27
- Decision date
- 2014-07-16
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE WAVE COMMUNICATOR MODEL 6280 SW VERSION V1.52.00;WAVE COMMUNICATOR MODEL 6290 SW VERSION V2.02.00;WAVE COMMUNICATOR MODEL 6498 SW VERSION V1.52.00;LATITUDE NXT SYSTEM SOFTWARE MODEL 6460 V.3.00.01; ANDCOMMUNICATOR ACCESSORY AND LITERATURE KIT MODEL 6250.
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