PMA P010012S245
- Device
- COGNIS PULSE GENERATORS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S245
- Product code
- LWP
- Decision date
- 2010-08-06
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE FRONT LINER COMPONENT USED ON THE TELIGEN AND COGNIS PULSE GENERATORS IN THE HYBRID ASSEMBLY AND TO REMOVE THE POLYIMIDE TAPE CURRENTLY APPLIED OVER THE ACCELEROMETER COMPONENT.
Current openFDA PMA Record#
- Device
- COGNIS PULSE GENERATORS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S245
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2010-08-06
- Decision code
- APPR
- Date received
- 2010-07-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE FRONT LINER COMPONENT USED ON THE TELIGEN AND COGNIS PULSE GENERATORS IN THE HYBRID ASSEMBLY AND TO REMOVE THE POLYIMIDE TAPE CURRENTLY APPLIED OVER THE ACCELEROMETER COMPONENT.