Premarket Approval (PMA)

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: INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
• Generic Name: Barrier, absorbable, adhesion
• Applicant: ETHICON, Inc.; 1000 Rte. 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS-ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO.