PMA P910077S126
- Device
- VENTAK PRX/VENTAK MINI FAMILIES OF ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S126
- Product code
- LWS
- Decision date
- 2012-11-09
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
Current openFDA PMA Record#
- Device
- VENTAK PRX/VENTAK MINI FAMILIES OF ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S126
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-11-09
- Decision code
- OK30
- Date received
- 2012-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.