PMA P910077S143
- Device
- LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S143
- Product code
- LWS
- Decision date
- 2014-07-16
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order 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.
Current openFDA PMA Record#
- Device
- LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S143
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-07-16
- Decision code
- APPR
- Date received
- 2014-05-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.