|
Device | TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS 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 | S078 |
Date Received | 10/26/2015 |
Decision Date | 04/28/2016 |
Product Codes |
DTB NVN NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the reassessment of microbiological levels for cleanrooms. |