|
Device | RES-Q(TM) MICRON ICD SYSTEM |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940008 |
Supplement Number | S005 |
Date Received | 03/24/1997 |
Decision Date | 04/25/1997 |
Withdrawal Date
|
07/20/2012 |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 531-30 RX2000 GRAPHICS PROGRAM MODULE |
Post-Approval Study | Show Report Schedule and Study Progress |