|
Device | SELUTE Pacing Lead Family |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P950001 |
Supplement Number | S028 |
Date Received | 05/27/2016 |
Decision Date | 06/23/2016 |
Product Code |
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 Alternate sterilization recipe and addition of a new sterilization release mechanism. |