MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
FDA premarket approval P890034/S006 · decided 1997-06-24
Approval details
- PMA number
- P890034
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Covidien
- Date received
- 1996-10-15
- Decision date
- 1997-06-24
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Boulder, CO
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.
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