PMA P880028S003
- Device
- DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
- Applicant
- Hospira, Inc.
- PMA number
- P880028
- Supplement
- S003
- Product code
- LTA
- Decision date
- 1995-12-15
- Classification
- Fluid, Hysteroscopy
- Generic name
- FLUID, HYSTEROSCOPY
- Approval order statement
- APPROVAL FOR DELETING THE TEST FOR ANTIGENIC IMPURITIES IN THE TESTING SPECIFICATIONS FOR THE DEXTRAN 70 (CODE 59479) BULK DRUG SUBSTANCE
Current openFDA PMA Record#
- Device
- DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
- Applicant
- Hospira, Inc.
- PMA number
- P880028
- Supplement
- S003
- Product code
- LTA
- Generic name
- FLUID, HYSTEROSCOPY
- Decision date
- 1995-12-15
- Decision code
- APPR
- Date received
- 1995-06-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR DELETING THE TEST FOR ANTIGENIC IMPURITIES IN THE TESTING SPECIFICATIONS FOR THE DEXTRAN 70 (CODE 59479) BULK DRUG SUBSTANCE