|Trade Name||PTCA CATHETERS|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to implement an alternate location for preparation of a hydrophilic coating solution component known as pre-bioslide and approval for an alternat supplier of the polymer initiator aibn.