PMA P010012S036
- Device
- CONTAK RENEWAL 1/3/3HE CRT-D DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S036
- Product code
- LWP
- Decision date
- 2007-03-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE CONSULT SOFTWARE MODEL 2845 V2.10 TO BE USED TO ENABLE THE ABILITY TO PROGRAM THE V-V TIMING INTERVAL IN THE CONTAK RENEWAL MODEL H135; CONTAK RENEWAL 2 MODELS H170 AND 175; AND CONTAK RENEWAL 3 HE MODELS H177 AND H179 CRT-D DEVICES.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL 1/3/3HE CRT-D DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S036
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2007-03-23
- Decision code
- APPR
- Date received
- 2004-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CONSULT SOFTWARE MODEL 2845 V2.10 TO BE USED TO ENABLE THE ABILITY TO PROGRAM THE V-V TIMING INTERVAL IN THE CONTAK RENEWAL MODEL H135; CONTAK RENEWAL 2 MODELS H170 AND 175; AND CONTAK RENEWAL 3 HE MODELS H177 AND H179 CRT-D DEVICES.