PMA P910077S020
- Device
- VENTAK PRX AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S020
- Product code
- LWS
- Decision date
- 1997-02-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.
Current openFDA PMA Record#
- Device
- VENTAK PRX AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S020
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1997-02-18
- Decision code
- APPR
- Date received
- 1996-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.