PMA P050011S003
- Device
- ADEPT ADHESION REDUCTION SOLUTION
- Applicant
- Baxter Healthcare Corp
- PMA number
- P050011
- Supplement
- S003
- Product code
- MCN
- Decision date
- 2012-05-17
- Classification
- Barrier, Absorbable, Adhesion
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THAT EXSUFFLATION SHOULD OCCUR PRIOR TO INSTILLING ADEPT.
Current openFDA PMA Record#
- Device
- ADEPT ADHESION REDUCTION SOLUTION
- Applicant
- Baxter Healthcare Corp
- PMA number
- P050011
- Supplement
- S003
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2012-05-17
- Decision code
- APPR
- Date received
- 2012-04-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THAT EXSUFFLATION SHOULD OCCUR PRIOR TO INSTILLING ADEPT.