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 (TC7) ABSORBABLE ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | P880047 |
Supplement Number | S008 |
Date Received | 09/04/2003 |
Decision Date | 10/21/2003 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS-ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO. |
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