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 | AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S109 |
Date Received | 09/16/2005 |
Decision Date | 10/14/2005 |
Product Code |
KRG |
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 ALTERNATE VENDOR OF QUADPOLAR FEEDTHROUGH ASSEMBLY FOR USE WITH AFFINITY, IDENTITY, INTEGRITY AND ENTITY FAMILY OF ICDS. |
|
|