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 | IMPLANTABLE CARDIOVETER DEFIBRILLATOR, DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA MINI, EL, ICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S382 |
Date Received | 09/16/2016 |
Decision Date | 10/13/2016 |
Product Code |
LWS |
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 Automate the process of applying medical adhesive to the battery feedthru assembly. |
|
|