|
Device | ESSENTIO; PROPONENT; ACCOLADE ; ALTRUA 2 PACEMAKERS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | N970003 |
Supplement Number | S185 |
Date Received | 01/08/2016 |
Decision Date | 02/03/2016 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Vertical integration of the manufacturing of the spring connector block housings for the devices. |