PMA P050011S004
- Device
- ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
- Applicant
- Baxter Healthcare Corp
- PMA number
- P050011
- Supplement
- S004
- Product code
- MCN
- Decision date
- 2013-07-02
- Classification
- Barrier, Absorbable, Adhesion
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- REPLACE THE CURRENT PEPTIDOGLYCAN (PG) TEST METHOD WITH A HIGH SENSITIVITY PG (HS-PG) TEST METHOD.
Current openFDA PMA Record#
- Device
- ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
- Applicant
- Baxter Healthcare Corp
- PMA number
- P050011
- Supplement
- S004
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2013-07-02
- Decision code
- OK30
- Date received
- 2013-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE CURRENT PEPTIDOGLYCAN (PG) TEST METHOD WITH A HIGH SENSITIVITY PG (HS-PG) TEST METHOD.