|
Device | INTERTACH(R)II MODELS 262-16 |
Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SINGLE |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P860007 |
Supplement Number | S017 |
Date Received | 02/01/1996 |
Decision Date | 03/22/1996 |
Withdrawal Date
|
07/19/2012 |
Product Code |
LWW |
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 THE INTRODUCTION OF LABELNG ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:INTERTACH II 262-16/262-16R |