PMA P910077S139
- Device
- MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S139
- Product code
- OSR
- Decision date
- 2014-04-11
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.
Current openFDA PMA Record#
- Device
- MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S139
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2014-04-11
- Decision code
- APPR
- Date received
- 2013-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.