Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceISOLINE 2CR DEFIBRILLATION LEADS
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA, Inc.
5640 Airline Rd..
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS021
Date Received05/16/2005
Decision Date01/15/2008
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) MODIFICATIONS TO THE SWIFT 1CT SERIES ICD LEAD TO CREATE A DUAL-COIL, INTEGRATED BIPOLAR, ACTIVE-FIXATION ICD LEAD. THE NEW LEAD WILL BE MARKETED UNDER THE NAME ISOLINE 2CR AND IS INDICATED FOR USE WITH ELA MEDICAL IMPLANTABLE DEFIBRILLATORS; 2) MANUFACTURING SITE AT SORIN BIOMEDICA CRM SRL, SALUGGIA, ITALY AND TWO STERILIZATION SITES AT BIOSTER SPA, BERGAMO, ITALY.
-
-