PMA P890034
- Device
- MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
- Applicant
- Covidien
- PMA number
- P890034
- Supplement
- S006
- Product code
- LSZ
- Decision date
- 1997-06-24
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.
Current openFDA PMA Record#
- Device
- MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
- Applicant
- Covidien
- PMA number
- P890034
- Supplement
- S006
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 1997-06-24
- Decision code
- APPR
- Date received
- 1996-10-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.