|
Device | HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S115 |
Date Received | 08/04/2006 |
Decision Date | 09/18/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS TO ADD SUPPORT FOR ATLAS II AND EPIC II ICD FAMILIES AND TO REMOVE THE SURFACE ECG FUNCTION. |