Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | INGEVITY™ non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY™ non-MRI Lead Passive Fixation, Ventricular, INGEV |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTONSCIENTIFIC 4100 HAMLINE AVENUE NORTH ST PAUL, MN 55112 |
PMA Number | P150012 |
Supplement Number | S106 |
Date Received | 01/11/2021 |
Decision Date | 01/13/2021 |
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 Add a new supplier of nitrile gloves, Ansell. |
|
|