| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | INTERGEL ADHESION PREVENTION SOLUTION |
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| Generic Name | Barrier, absorbable, adhesion |
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| Applicant | LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA, MN 55318 |
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| PMA Number | P990015 |
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| Date Received | 03/08/1999 |
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| Decision Date | 11/16/2001 |
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|
Withdrawal Date
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12/11/2007 |
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| Product Code |
MCN |
| Docket Number | 01M-0523 |
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| Notice Date | 11/21/2001 |
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| Advisory Committee |
Obstetrics/Gynecology |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE GYNECARE INTERGEL ADHESION PREVENTIION SOLUTION. THE DEVICE IS INDICATED FOR USE IN PATIENTS UNDERGOING OPEN, CONSERVATIVE GYNECOLOGIC SURGERY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE TO REDUCE POST-SURGICAL ADHESIONS. GYNECARE INTERGEL ADHESION PREVENTION SOLUTION IS ALSO INTENDED TO REDUCE THE LIKELIHOOD OF DEVELOPING MODERATE OR SEVERE POSTOPERATIVE ADNEXAL ADHESIONS IN THESE PATIENTS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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|
