PMA P840068S047
- Device
- DELTA PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S047
- Product code
- LWP
- Decision date
- 2010-09-14
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
Current openFDA PMA Record#
- Device
- DELTA PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S047
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2010-09-14
- Decision code
- APPR
- Date received
- 2010-08-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.