|
Device | RES-Q(TM) MICRON ICD SYSTEM |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940008 |
Supplement Number | S008 |
Date Received | 11/26/1997 |
Decision Date | 12/29/1997 |
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 a design change to the IS-1 connector of the existing defibrillation/pacing leads. |
Post-Approval Study | Show Report Schedule and Study Progress |