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. |
|
Device | ISOFLEX (ISOFLEX S, ISOFLEX P, ISOFLEX OPTIM) AND PASSIVE PLUS FAMILY OF LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960030 |
Supplement Number | S036 |
Date Received | 04/03/2012 |
Decision Date | 05/03/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS. |
|
|