|
Device | AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER |
Generic Name | PULSE-GENERATOR, PROGRAM MODULE |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880065 |
Supplement Number | S009 |
Date Received | 12/08/2003 |
Decision Date | 01/07/2004 |
Withdrawal Date
|
09/20/2007 |
Product Code |
LOT |
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 CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION. |