|
Device | INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940008 |
Supplement Number | S016 |
Date Received | 03/27/2001 |
Decision Date | 04/25/2001 |
Withdrawal Date
|
07/20/2012 |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE FOLLOW-UP INDICATORS REFLECTING BATTERY LONGEVITY. |