PMA P860007S018

Device: INTERTACH II MODELS 262-16
Applicant: Boston Scientific
PMA number: P860007
Supplement: S018
Product code: LWW
Decision date: 1996-08-19
Generic name: PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
Approval order statement: APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS

Current openFDA PMA Record

Device: INTERTACH II MODELS 262-16
Applicant: Boston Scientific
PMA number: P860007
Supplement: S018
Product code: LWW
Generic name: PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
Decision date: 1996-08-19
Decision code: APPR
Date received: 1996-03-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS