|
Device | CELSIUS FLTR UNI -DIRECTIONAL CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S058 |
Date Received | 07/17/2015 |
Decision Date | 08/18/2015 |
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 ACCEPTANCE OF A NEW PRODUCTION MACHINE FOR PERFORMING REFLOW OF THE QUAD LUMEN TIP. |