Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | GYNECARE INTERGEL ADHESION PREVENTION SOLUTION |
Generic Name | Barrier, absorbable, adhesion |
Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. CHASKA, MN 55318 |
PMA Number | P990015 |
Supplement Number | S002 |
Date Received | 09/19/2002 |
Decision Date | 03/18/2003 |
Withdrawal Date
|
12/11/2007 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day 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 LABELING IN RESPONSE TO ADVERSE EVENT REPORTS OF ADDITIONAL SURGERY, INCLUDING HYSTERECTOMY, THAT OCCURRED FOLLOWING POST-OPERATIVE PAIN, ASCITES, NON-INFECTIOUS PERITONITIS, AND/OR POSSIBLE DELAYED CLEARANCE OF GYNECARE INTERGEL. |
|
|