PMA P960040S467
- Device
- VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S467
- Product code
- LWS
- Decision date
- 2021-07-23
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval to suspend enrollment for six (6) months for MANAGE-HF.
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
- S467
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-07-23
- Decision code
- APPR
- Date received
- 2021-07-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to suspend enrollment for six (6) months for MANAGE-HF.