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 | ADX PULSE GENERATOR |
Generic Name | Programmer, pacemaker |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S087 |
Date Received | 08/05/2003 |
Decision Date | 08/15/2003 |
Withdrawal Date
|
06/20/2007 |
Product Codes |
DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE FIRMWARE OF THE ADX FAMILY OF PULSE GENERATORS AND FOR PROGRAMMING SOFTWARE MODEL 3307 V4.4.2A TO IMPLEMENT THE MODIFIED FIRMWARE IN IMPLANTED DEVICES. |
|
|