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. |
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Device | NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | NELLCOR PURITAN BENNETT, INC. 2200 FARADAY AVE. CARLSBAD, CA 92008-7208 |
PMA Number | P880013 |
Supplement Number | S009 |
Date Received | 04/22/2002 |
Decision Date | 12/17/2002 |
Withdrawal Date
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08/29/2007 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA. |
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