|
Device | INGEVITY MRI LEAD, INGEVITY Non-MRI Lead |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTONSCIENTIFIC 4100 HAMLINE AVENUE NORTH ST PAUL, MN 55112 |
PMA Number | P150012 |
Supplement Number | S010 |
Date Received | 07/05/2016 |
Decision Date | 07/26/2016 |
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 Modified welding fixture for use in the manufacturing of the Ingevity family of pacemaker leads. |