|
Device | TRANSVENOUS BIPOLAR PACING LEAD |
Generic Name | Permanent defibrillator electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960006 |
Supplement Number | S029 |
Date Received | 12/01/2010 |
Decision Date | 05/19/2011 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO LASER WELDING EQUIPMENT USED IN THE MANUFACTURE OF PACING LEADS. |