PMA P910077S125
- Device
- VENTAK PRX AND VENTAK. MINI AUTOMATIC IMPLANTABLE CARDIOVERTER
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S125
- Product code
- LWS
- Decision date
- 2012-10-24
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE TO THE MAIN CONTROL BOARD MANUFACTURING LINE.
Current openFDA PMA Record#
- Device
- VENTAK PRX AND VENTAK. MINI AUTOMATIC IMPLANTABLE CARDIOVERTER
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S125
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-10-24
- Decision code
- OK30
- Date received
- 2012-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MAIN CONTROL BOARD MANUFACTURING LINE.