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. |
|
Device | HFV INFANT STAR VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | NELLCOR PURITAN BENNETT, INC. 2200 FARADAY AVE. CARLSBAD, CA 92008-7208 |
PMA Number | P880013 |
Supplement Number | S008 |
Date Received | 03/30/1998 |
Decision Date | 04/07/1998 |
Withdrawal Date
|
08/29/2007 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
|
|