|
Device | ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S045 |
Date Received | 03/19/2009 |
Decision Date | 04/16/2009 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MINOR LABELING CHANGES THAT ENHANCE INSTRUCTIONS FOR SAFE DEVICE USE IN THE TENDRIL ST MODEL 1888 USER¿S MANUAL. |