|
Device | LOCATOR STEERABLE STYLET |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S005 |
Date Received | 03/04/1999 |
Decision Date | 04/09/1999 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the User's Manual and package label for the Locator(TM) Steerable Stylet Model 4036. |