|
Device | SELUTE LEAD SYSTEM FAMILY |
Generic Name | Permanent defibrillator electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P950001 |
Supplement Number | S023 |
Date Received | 03/26/2012 |
Decision Date | 04/23/2012 |
Product Code |
NVY |
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 IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL. |