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.
 
DeviceESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberN970003
Supplement NumberS181
Date Received07/17/2015
Decision Date08/08/2015
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADD AN AUTOMATED VISION INSPECTION SYSTEM FOR THE COIL SPRING INNER DIAMETER OF THE REFERENCED DEVICES AT THE SUPPLIER, BAL SEAL.
-
-