|
Device | ENDOTAK RELIANCE IS-I PASSIVE FIXATION |
Generic Name | Permanent defibrillator electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S091 |
Date Received | 12/14/2010 |
Decision Date | 01/05/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR DRUG MATERIAL AND SUPPLIER CHANGES AS WELL AS DISTAL TIP DESIGN CHANGES. |
Approval Order | Approval Order |