PMA P910077S134
- Device
- ZOOM LATITUDE PROGRAMMING SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S134
- Product code
- LWS
- Decision date
- 2013-06-20
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR USE OF AN ALTERNATE ANTENNA (MODEL 3123) WITH THE LATITUDE PROGRAMMER/RECORDER/MONITOR MODEL 3120 AND ASSOCIATED DEVICE LABELING.
Current openFDA PMA Record#
- Device
- ZOOM LATITUDE PROGRAMMING SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S134
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-06-20
- Decision code
- APPR
- Date received
- 2013-05-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USE OF AN ALTERNATE ANTENNA (MODEL 3123) WITH THE LATITUDE PROGRAMMER/RECORDER/MONITOR MODEL 3120 AND ASSOCIATED DEVICE LABELING.