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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHANCOCK II PORCINE BIOPROSTHESIS
Generic Namereplacement heart valve
ApplicantMEDTRONIC HEART VALVES
PMA NumberP980043
Date Received10/29/1998
Decision Date09/28/1999
Docket Number 99M-4279
Notice Date 10/15/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the medtronic hancock(r) ii bioprosthetic heart valve, models t505 (odd sizes 21 through 29 mm) and t510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves.
Approval Order Approval Order
Supplements: S001 S002 S004 S005 S007 S008 
S009 S010 S012 S013 S014 S015 
S016 S017 S018 S020 S021 S022 
S023 S024 S025 S026 S027 S028 
S029 S030 S032 S033 S034 S035 
S036 S037 S038 S039 S040 
-
-