|
Device | ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S029 |
Date Received | 02/06/2009 |
Decision Date | 02/27/2009 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement MODIFICATION TO THE ALLOWABLE COMBINATIONS OF MEDRAD INTERVENTIONAL/ POSSIS (MIP) PRODUCTS THAT MAY BE STERILIZED WITH AN ETHYLENE OXIDE (EO) STERILIZATION CYCLE. |