PMA P880027

Device: PTCA CATHETERS
Applicant: Boston Scientific
PMA number: P880027
Supplement: S057
Product code: LOX
Decision date: 2005-10-31
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS. THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.

Current openFDA PMA Record

Device: PTCA CATHETERS
Applicant: Boston Scientific
PMA number: P880027
Supplement: S064
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2005-10-31
Decision code: APPR
Date received: 2005-03-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS. THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.