PMA P010012S411
- Device
- CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S411
- Product code
- NIK
- Decision date
- 2016-05-03
- 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 an alternate capacitor to be used in the communications module.
Current openFDA PMA Record#
- Device
- CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S411
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-05-03
- Decision code
- APPR
- Date received
- 2016-02-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate capacitor to be used in the communications module.