|
Device | ADEPT ADHESION REDUCTION SOLUTION |
Generic Name | Barrier, absorbable, adhesion |
Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD MCGAW PARK, IL 60085 |
PMA Number | P050011 |
Supplement Number | S003 |
Date Received | 04/24/2012 |
Decision Date | 05/17/2012 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THAT EXSUFFLATION SHOULD OCCUR PRIOR TO INSTILLING ADEPT. |