|
Device | INGEVITY+ and INGEVITY MRI Pace/Sense leads |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTONSCIENTIFIC 4100 HAMLINE AVENUE NORTH ST PAUL, MN 55112 |
PMA Number | P150012 |
Supplement Number | S145 |
Date Received | 05/09/2023 |
Decision Date | 05/17/2023 |
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 Introduction of a digital microscope to verify removal of medical adhesive during the Drug Collar Bonding manufacturing process. |