PMA P980009

Device: MAGIC WALLSTENT ENDOPROSTHESIS
Applicant: Boston Scientific Scimed, Inc.
PMA number: P980009
Supplement: S005
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: MAGIC WALLSTENT ENDOPROSTHESIS
Applicant: Boston Scientific Scimed, Inc.
PMA number: P980009
Supplement: S013
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.