|
Device | EPIC/EPIC+/ATLAS/ATLAS+/CONVERT/CONVERT+ ICDS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S139 |
Date Received | 04/25/2007 |
Decision Date | 05/23/2007 |
Product Code |
NVZ |
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 CHANGES TO THE EPIC ICD AND CRT-D SELF-TEST MANUFACTURING SOFTWARE TEST METHOD. |