MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR

FDA Premarket Approval P890034 S005

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.

Pre-market Approval Supplement Details

Approval for an proximal monitoring endotracheal tube adapter for use with the adult star model 1010 ultrahigh frequency ventilator - the proximal monitoring adapter will be marketed under the new trade name as the "proximal monitoring adapter"

DeviceMODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
Generic NameVentilator, High Frequency
ApplicantCovidien
Date Received1995-06-12
Decision Date1995-12-28
PMAP890034
SupplementS005
Product CodeLSZ 
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Covidien 6135 Gunbarrel Ave. boulder, CO 80301

Supplemental Filings

Supplement NumberDateSupplement Type
P890034Original Filing
S006 1996-10-15 Normal 180 Day Track
S005 1995-06-12 Normal 180 Day Track
S004 1993-10-22 Normal 180 Day Track
S003 1993-12-02 Normal 180 Day Track
S002 1993-11-08 Normal 180 Day Track
S001 1993-08-12 Normal 180 Day Track

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