|
Device | CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY SPIRAL FAMILIES |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S266 |
Date Received | 04/01/2011 |
Decision Date | 04/29/2011 |
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 CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS. |