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

510(k) Premarket Notification
  • 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
Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(K) Number K071957
Device Name PINNACLE PELVIC FLOOR REPAIR KITS
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough,  MA  01752
Contact michelle berry
Regulation Number878.3300
Classification Product Code
OTP  
Date Received07/16/2007
Decision Date 11/08/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-