Boston Scientific Corp Marina Bay Cust Fulfillment Center

FDA Filings

This page includes the latest FDA filings for Boston Scientific Corp Marina Bay Cust Fulfillment Center. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1225687
FEI Number3001451463
NameBoston Scientific Corp., Marina Bay Cust. Fulfillment Center
Owner & OperatorBoston Scientific Corporation
Contact Address300 Boston Scientific Way
Marlborough MA 01752 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address500 Commander Shea Boulevard
QUINCY, MA 02171 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Monorail (MR) and Over-the-Wire (OTW)2020-03-25
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Flextome Cutting Balloon Microsurgical Dilatation Device2020-03-25
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
ELUVIA Drug-Eluting Vascular Stent System2018-09-24
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
XXL Esophageal Balloon Dilatation Catheter2016-12-05
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
MaxForce TTS Esophageal High Performance Balloon Dilatation Catheter2016-12-05
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
CRE Fixed Wire Esophageal Balloon Dilatation Catheter2016-12-05
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System2015-10-05
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Innova Vascular Self-Expanding Stent System2015-08-05
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
WATCHMAN Left Atrial Appendage Closure Device with Delivery System2015-03-17
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
WATCHMAN Access System Access Sheath with Dilator2015-03-17
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AngioJet XMI Thrombectomy Set2014-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AngioJet Ultra 5000A Console2014-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AngioJet Spiroflex VG Thrombectomy Set2014-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AngioJet Spiroflex Thrombecotmy Set2014-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AngioJet Distaflex Thrombectomy Set2014-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AngioJet PE Thrombectomy Set2014-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
REBEL Platinum Chromium Coronary Stent System2014-07-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percutaneous Tract Kit with Zipwire Guidewire2014-07-14
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Lingeman Percutaneous Tract Kit with Zipwire Guidewire2014-07-14
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Retrograde Intrarenal Surgery (RIRS) Kit2014-06-23
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Flexible Ureteroscopy (URS) Kit2014-06-23
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percutaneous Nephrolithotomy (PNL) Kit2014-06-23
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
RX Cholangiogram Kit2013-08-12
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Alair RF Controller Accessory Kit2013-07-12
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Epic Vascular Self-Expanding Stent System2012-12-13
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System2011-11-28
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System2011-11-28
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
NC Emerge PTCA Dilatation Catheter2010-12-17
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Gateway PTA Dilatation Catheter2010-12-17
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Emerge Push PTCA Dilatation Catheter2010-12-17
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Emerge PTCA Dilatation Catheter2010-12-17
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Alair RF Controller Accessory Kit2010-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Alair Bronchial Thermoplasty Controller2010-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Alair Bronchial Thermoplasty Catheter2010-10-29
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Quantum Maverick PTCA Dilatation Catheter2008-01-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
NC Quantum Apex PTCA Dilatation Catheter2008-01-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Maverick PTCA Dilatation Catheter2008-01-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Maverick 2 PTCA Dilatation Catheter2008-01-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Apex Push PTCA Dilatation Catheter2008-01-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Apex PTCA Dilatation Catheter2008-01-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Apex Flex PTCA Dilatation Catheter2008-01-22
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
VTC Nephrostomy Catheters System2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
VTC Nephrostomy Catheters System Kit2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
TLA Introducer Needle and Sheath Set2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Re-entry Malecot Nephrostomy Catheter Set2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percutaneous Access Set2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percutaneous Access Needle2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percutaneous Access Needle with Echogenic Tip2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percuflex Locking Loop Nephrostomy Catheter2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percuflex Locking Loop Nephrostomy Catheter with Fader Tip2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
NaviGuide Percutaneous Access Needle2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Malecot Nephrostomy Catheter Set2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
JINRO Pigtail Nephrostomy Catheter2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
JINRO Pigtail Nephrostomy Catheter Placement Kit2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
JINRO Pigtail Nephrostomy Catheter Kit2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Flexima Nephrostomy Catheter System2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Flexima Nephrostomy Catheter System with Dissolving Tip2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Flexima Nephrostomy Catheter System Kit2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Flexima Nephrostomy Catheter System Kit with Dissolving Tip2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit2005-08-01
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Stainless Steel Guidewire Guidewire1999-03-08
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Percufix Catheter Cuff Catheter Cuff1999-03-08
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Ntinol Guidewire Guidewire1999-03-08
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Expel Large Capacity Drainage Catheter Connecting Tube Connecting Tube1999-03-08
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Connecting Tubes Connecting Tube for Drainage Bag with Funnel Adaptors1999-03-08
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AccuStick II Introducer System1999-03-08
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Expel Large Capacity Drainage Catheter MPD Large Capacity Drainage Catheter1996-06-26
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Expel Drainage Catheter with Twist-Loc Hub MPDL Drainage Catheter1996-06-26
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Expel Drainage Catheter with Twist-Loc Hub MPDL Drainage Catheter Kit1996-06-26
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
Expel Drainage Catheter MPD Drainage Catheter1996-06-26
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center [Boston Scientific Corporation]
AccuStick Needle Introducer Needle1983-09-09

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