|
Device | ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S106 |
Date Received | 09/04/2012 |
Decision Date | 10/03/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING. |