PMA P010012S011
- Device
- CONTAK CD 2 CRT-D SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S011
- Product code
- NIK
- Decision date
- 2003-07-10
- 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 2844 VERSION 3.6
Current openFDA PMA Record#
- Device
- CONTAK CD 2 CRT-D SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S011
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2003-07-10
- Decision code
- APPR
- Date received
- 2003-03-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6