PMA P940031S057
- Device
- VIGOR DR/SR PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S057
- Product code
- LWP
- Decision date
- 2006-07-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
Current openFDA PMA Record#
- Device
- VIGOR DR/SR PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S057
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-07-26
- Decision code
- OK30
- Date received
- 2006-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.