PMA P960040S408
- Device
- Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient and Teligen Automatic Implantable Cardiovetr Defibrillator System
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S408
- Product code
- LWS
- Decision date
- 2018-01-07
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for multiple software upgrades and updates for the Model 3300 Latitude Programming System.
Current openFDA PMA Record#
- Device
- Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient and Teligen Automatic Implantable Cardiovetr Defibrillator System
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S408
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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.