PMA P840068S048
- Device
- DELTA PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S048
- Product code
- LWP
- Decision date
- 2011-05-17
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
Current openFDA PMA Record#
- Device
- DELTA PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S048
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2011-05-17
- Decision code
- APPR
- Date received
- 2011-03-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.