• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprosthesis, penis, inflatable
Generic Nameprosthesis, penis, inflatable
Regulation Number876.3350
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberN970012
Supplement NumberS098
Date Received12/05/2013
Decision Date01/02/2014
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Proposed addition of an alternative method (automated) for applying a plug to the kink resistant tubing during the manufacturing application of an antimicrobial surface treatment.