PMA P910077S008
- Device
- VENTAK MINI AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S008
- Product code
- LWS
- Decision date
- 1995-12-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE VENTAK MINI AICD SYSTEM, WHICH INCLUDES:MODEL NUMBERS 1645, 1740, 1741, 1745, AND 1746 PULSE GENERATORS; MODEL 2840 SOFTWARE APPLICATION; MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU); AND MODEL 6996 DF-1 PLUG
Current openFDA PMA Record#
- Device
- VENTAK MINI AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S008
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1995-12-21
- Decision code
- APPR
- Date received
- 1995-06-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE VENTAK MINI AICD SYSTEM, WHICH INCLUDES:MODEL NUMBERS 1645, 1740, 1741, 1745, AND 1746 PULSE GENERATORS; MODEL 2840 SOFTWARE APPLICATION; MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU); AND MODEL 6996 DF-1 PLUG