PMA P960040S444
- Device
- VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S444
- Product code
- LWS
- Decision date
- 2019-11-15
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Remove a redundant process monitor inspection on the Tachy battery stack's discrete separator.
Current openFDA PMA Record#
- Device
- VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S444
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-11-15
- Decision code
- OK30
- Date received
- 2019-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove a redundant process monitor inspection on the Tachy battery stack's discrete separator.