PMA P910077S050
- Device
- MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S050
- Product code
- LWS
- Decision date
- 2005-08-15
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SECOND INTERNAL ANTENNA TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR, A LABELING UPDATE FOR THE MODEL 3122 ANTENNA ACCESSORY, CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12, AND MINOR MANUFACTURING PROCESS CHANGES.
Current openFDA PMA Record#
- Device
- MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S050
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2005-08-15
- Decision code
- APPR
- Date received
- 2005-03-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SECOND INTERNAL ANTENNA TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR, A LABELING UPDATE FOR THE MODEL 3122 ANTENNA ACCESSORY, CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12, AND MINOR MANUFACTURING PROCESS CHANGES.