|
Device | ACUITY STEERABLE LEAD SYSTEM |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P050046 |
Supplement Number | S032 |
Date Received | 09/01/2021 |
Decision Date | 09/24/2021 |
Product Code |
OJX |
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 Use a new controlled environment area at the Boston Scientific Dorado, Puerto Rico facility. |