|
Device | VARIOUS FAMILIES OF PROMOTE AND UNIFY |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S276 |
Date Received | 09/12/2011 |
Decision Date | 11/01/2011 |
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 |
Approval Order Statement APPROVAL FOR THE INTRODUCTION OF THE IS4/DF4 PORT PLUG ACCESSORY MODEL AC-IS4PP FOR USE WITH ALL SJM DF4 OR IS4 HEADER PORTS. |