PMA P010012S029
- Device
- CONTAK RENEWAL AND CONTAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S029
- Product code
- NIK
- Decision date
- 2004-08-06
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 2.4.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL AND CONTAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S029
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2004-08-06
- Decision code
- APPR
- Date received
- 2004-06-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 2.4.