PMA P970061

Device: RADIUS CORONARY STENT WITH DELIVERY SYSTEM
Applicant: Boston Scientific Scimed, Inc.
PMA number: P970061
Supplement: S009
Product code: MAF
Decision date: 2005-10-31
Generic name: STENT, CORONARY
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: RADIUS CORONARY STENT WITH DELIVERY SYSTEM
Applicant: Boston Scientific Scimed, Inc.
PMA number: P970061
Supplement: S021
Product code: MAF
Generic name: STENT, CORONARY
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.