|
Device | VITALITY & VITALITY 2 DEVICE FAMILY |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S160 |
Date Received | 01/17/2008 |
Decision Date | 02/13/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO ADD WARNING INFORMATION REGARDING CORRECT DEVICE IMPLANT ORIENTATION TO THE LABELING OF THE DEVICES. |