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.
 
DeviceSpiration Valve System (SVS)
Generic NameValve, pulmonary
ApplicantGyrus Acmi, Inc.
6675 185th Ave. NE
Redmond, WA 98052
PMA NumberP180007
Supplement NumberS015
Date Received04/15/2026
Decision Date05/07/2026
Product Code NJK 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The firm is submitting this 30-Day Notice of a change in the verification and validation process of the Water Treatment System. The firm is adding endotoxin testing for the water samples and related process modifications to the manufacturing work instruction.
-
-