|
Device | TENDRIL/PASSIVE PLUS/AV PLUS DX |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S006 |
Date Received | 07/02/1999 |
Decision Date | 11/10/1999 |
Product Code |
DTB |
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 | No |
Approval Order Statement Approval for the use of two alternate medical adhesives. |