|
Device | ESSENTIO MRI Models L110, L111, L131; |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTONSCIENTIFIC 4100 HAMLINE AVENUE NORTH ST PAUL, MN 55112 |
PMA Number | P150012 |
Supplement Number | S020 |
Date Received | 11/18/2016 |
Decision Date | 12/12/2016 |
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 Additional manufacturing inspection step along with associated specification and inspection criteria that will allow pulse generator case half discontinuities to be distinguished from dents. |