|
Device | TENDRIL MODEL 1488T/TC & 1688T/TC LEADS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S020 |
Date Received | 05/31/2006 |
Decision Date | 06/26/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO THE INSPECTION PROCESS FOR MEDICAL ADHESIVE ON THE ELECTRODE RING DURING PRODUCTION OF THE LEADS. |