PMA P910077S012
- Device
- VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S012
- Product code
- LWS
- Decision date
- 1996-04-29
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE VENTAK MINI HC (MODELS 1742, 1743, AND 1640) WHICH IS AN ACTIVE CAN VERSION OF YOUR COMMERCIALLY AVAILABLE VENTAK MINI AICD SYSTEM AND THE VENTAK MINI II HC AICD SYSTEM (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH IS A DOWN-SIZED VERSION OF THE VENTAK MINI HC AICD SYSTEM. THE MINI II HC MAXIMUM ENERGY LEVELS ARE 25 AND 27 JEWELS WHERE THE MINI HC MAXIMUM ENERGY LEVEL IS 29 JEWELS
Current openFDA PMA Record#
- Device
- VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S012
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-04-29
- Decision code
- APPR
- Date received
- 1995-09-12
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR THE VENTAK MINI HC (MODELS 1742, 1743, AND 1640) WHICH IS AN ACTIVE CAN VERSION OF YOUR COMMERCIALLY AVAILABLE VENTAK MINI AICD SYSTEM AND THE VENTAK MINI II HC AICD SYSTEM (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH IS A DOWN-SIZED VERSION OF THE VENTAK MINI HC AICD SYSTEM. THE MINI II HC MAXIMUM ENERGY LEVELS ARE 25 AND 27 JEWELS WHERE THE MINI HC MAXIMUM ENERGY LEVEL IS 29 JEWELS