PMA P010012S233
- Device
- COGNIS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S233
- Product code
- LWP
- Decision date
- 2010-03-12
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE SECOND SUPPLIER WITH A DESIGN CHANGE FOR THE CAPACITORS USED IN THE COGNIS/TELIGEN FAMILY OF DEVICES.
Current openFDA PMA Record#
- Device
- COGNIS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S233
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2010-03-12
- Decision code
- APPR
- Date received
- 2010-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE SECOND SUPPLIER WITH A DESIGN CHANGE FOR THE CAPACITORS USED IN THE COGNIS/TELIGEN FAMILY OF DEVICES.