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 | INTERCEED ABSORBABLE ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | P880047 |
Supplement Number | S012 |
Date Received | 04/22/2008 |
Decision Date | 11/26/2008 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING SITES LOCATED AT: 1) ETHICON SARL, NEUCHATEL, SWITZERLAND; 2) ETHICON SARL, MARIN SWITZERLAND (WAREHOUSE); AND 3) STUDER AF/WERK HARD, DANIKEN, SWITZERLAND (CONTRACT STERILIZER). |
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