Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ACUITY STEERABLE IS-1 LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P050046 |
Supplement Number | S013 |
Date Received | 01/24/2012 |
Decision Date | 02/29/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN. |
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