|
Device | SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD FAMILIES |
Generic Name | Permanent defibrillator electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960006 |
Supplement Number | S037 |
Date Received | 11/08/2012 |
Decision Date | 12/05/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REPLACE THE TRACEABILITY AND TRACKING SYSTEM. |