PMA P860007S017

Device: INTERTACH(R)II MODELS 262-16
Applicant: Boston Scientific
PMA number: P860007
Supplement: S017
Product code: LWW
Decision date: 1996-03-22
Generic name: PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
Approval order statement: APPROVAL FOR THE INTRODUCTION OF LABELNG ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:INTERTACH II 262-16/262-16R

Current openFDA PMA Record

Device: INTERTACH(R)II MODELS 262-16
Applicant: Boston Scientific
PMA number: P860007
Supplement: S017
Product code: LWW
Generic name: PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
Decision date: 1996-03-22
Decision code: APPR
Date received: 1996-02-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE INTRODUCTION OF LABELNG ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:INTERTACH II 262-16/262-16R