PMA P010012S234
- Device
- COGNIS PULSE GENERATORS - MODELS N118 & N119
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S234
- Product code
- LWP
- Decision date
- 2010-04-02
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR 2ND SUPPLIER (IXYS) TO PROVIDE SCR/ANODE GATE THYRISTORS FOR THE SUPER OUTPUT MODULE (SOM) OF THE COGNIS/TELIGEN PGS.
Current openFDA PMA Record#
- Device
- COGNIS PULSE GENERATORS - MODELS N118 & N119
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S234
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2010-04-02
- Decision code
- APPR
- Date received
- 2010-03-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 2ND SUPPLIER (IXYS) TO PROVIDE SCR/ANODE GATE THYRISTORS FOR THE SUPER OUTPUT MODULE (SOM) OF THE COGNIS/TELIGEN PGS.