PMA P910065S003
- Device
- AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S003
- Product code
- LTJ
- Decision date
- 2002-09-09
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- APPROVAL TO CHANGE THE LOCATION OF THE MANUFACTURING FACILITY OF THE ASCITES FLUID USED IN THE PREPARATION OF THE MONOCLONAL ANTIBODIES FROM THE TOSOH TOKYO RESEARCH CENTER IN AYASE, JAPAN TO NISSEIKEN, CO. LTD. IN TOKYO, JAPAN.
Current openFDA PMA Record#
- Device
- AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S003
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2002-09-09
- Decision code
- APPR
- Date received
- 2002-01-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE THE LOCATION OF THE MANUFACTURING FACILITY OF THE ASCITES FLUID USED IN THE PREPARATION OF THE MONOCLONAL ANTIBODIES FROM THE TOSOH TOKYO RESEARCH CENTER IN AYASE, JAPAN TO NISSEIKEN, CO. LTD. IN TOKYO, JAPAN.