|
Device | ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers |
Generic Name | implantable pulse generator, pacemaker (non-crt) |
Applicant |
BOSTONSCIENTIFIC |
4100 hamline avenue north |
st paul, MN 55112 |
|
PMA Number | P150012 |
Supplement Number | S002 |
Date Received | 05/02/2016 |
Decision Date | 05/31/2016 |
Product Codes |
LWP
NVN
|
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
Implementation of the following previously accepted manufacturing changes: 1) Removal of a plating process on the crystal oscillator component; 2) modifications to the crystal oscillator manufacturing process; 3) addition of an alternate supplier of a battery raw material; 4) addition of an alternate supplier of the power conductor component; 5) addition of an alternate supplier of the telemetry coils; 6) addition of an alternate supplier of capacitors; 7) addition of an automated visual inspection system for coil springs; 8) addition of an automated packaging line; and 9) vertical integration of the spring connector housing block. |