PMA P910077S121

Device: VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER
Applicant: Boston Scientific
PMA number: P910077
Supplement: S121
Product code: LWS
Decision date: 2012-06-19
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: APPROVAL FOR THE ADDITION OF THE OPTION TO CONNECT THE LATTITUDE COMMUNICATOR TO AN OFF-THE-SHELF COMMERCIALLY AVAILABLE CELLULAR MODEM.

Current openFDA PMA Record#

Device: VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER
Applicant: Boston Scientific
PMA number: P910077
Supplement: S121
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2012-06-19
Decision code: APPR
Date received: 2012-05-09
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE OPTION TO CONNECT THE LATTITUDE COMMUNICATOR TO AN OFF-THE-SHELF COMMERCIALLY AVAILABLE CELLULAR MODEM.