PMA P010012S467
- Device
- Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S467
- Product code
- NIK
- Decision date
- 2018-01-07
- 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 multiple software upgrades and updates for the Model 3300 Latitude Programming System.
Current openFDA PMA Record#
- Device
- Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S467
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-01-07
- Decision code
- APPR
- Date received
- 2017-10-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for multiple software upgrades and updates for the Model 3300 Latitude Programming System.