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 | MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Covidien 6135 GUNBARREL AVE. BOULDER, CO 80301 |
PMA Number | P890034 |
Supplement Number | S006 |
Date Received | 10/15/1996 |
Decision Date | 06/24/1997 |
Withdrawal Date
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02/25/2011 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW MANUFACTURING FACILITY AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA. |
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