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. |
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Device | ABSORBABLE ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | P880047 |
Supplement Number | S015 |
Date Received | 04/18/2011 |
Decision Date | 06/17/2011 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LARGER INTERCEED PRODUCT THAT MEASURES 5¿X6¿ IN SIZE. THE DEVICE, AS MODIFIED, IS INDICATED AS AN ADJUVANT IN OPEN (LAPAROTOMY) GYNECOLOGIC PELVIC SURGERY FOR REDUCING THE INCIDENCE OF POSTOPERATIVE PELVIC ADHESIONS AFTER METICULOUS HEMOSTASIS IS ACHIEVED. |
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