PMA P910077S014

Device: MODEL 2901 PROGRAMMER
Applicant: Boston Scientific
PMA number: P910077
Supplement: S014
Product code: KRG
Decision date: 1996-11-07
Classification: Programmer, Pacemaker
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR A 1)NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VENTAK PRXII/PRXIII, MINI PULSE GENERTORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC. (EMD), 4065 THEURER BLVD., WINONA, MN 55987

Current openFDA PMA Record#

Device: MODEL 2901 PROGRAMMER
Applicant: Boston Scientific
PMA number: P910077
Supplement: S014
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 1996-11-07
Decision code: APPR
Date received: 1996-03-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A 1)NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VENTAK PRXII/PRXIII, MINI PULSE GENERTORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC. (EMD), 4065 THEURER BLVD., WINONA, MN 55987