PMA P910077S140
- Device
- LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S140
- Product code
- LWS
- Decision date
- 2014-06-20
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order 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.
Current openFDA PMA Record#
- Device
- LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S140
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-06-20
- Decision code
- APPR
- Date received
- 2013-11-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.