• 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.
 
DeviceABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Classification Nameabsorbable coronary drug-eluting stent
Generic Nameabsorbable coronary drug-eluting stent
Applicant
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara, CA 95054
PMA NumberP150023
Supplement NumberS002
Date Received07/29/2016
Decision Date08/25/2016
Product Code
PNY[ Registered Establishments with PNY ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling changes to clarify the interpretation of the ABSORB III clinical data for geriatric patients in the Absorb GT1 BVS Instructions for Use.
-
-