|
Device | NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990025 |
Supplement Number | S013 |
Date Received | 07/31/2007 |
Decision Date | 08/23/2007 |
Product Code |
LPB |
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 INCREASING THE STERILIZATION PALLET SIZE FORM A 6-PALLET LOAD TO A 10-PALLET LOAD. |