ADEPT ADHESION REDUCTION SOLUTION
FDA premarket approval P050011/S003 · decided 2012-05-17
Approval details
- PMA number
- P050011
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADEPT ADHESION REDUCTION SOLUTION
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corp
- Date received
- 2012-04-24
- Decision date
- 2012-05-17
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Mcgaw Park, IL
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THAT EXSUFFLATION SHOULD OCCUR PRIOR TO INSTILLING ADEPT.
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