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 | GYNECARE INTERCEED™ Absorbable Adhesion Barrier |
Generic Name | Barrier, absorbable, adhesion |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | P880047 |
Supplement Number | S052 |
Date Received | 11/21/2022 |
Decision Date | 12/20/2022 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes related to improvements to the splice detection, vision system, and reject mechanism of the Automated Foil Sealer Equipment (SL1099) used to seal the foil pouches at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing site. |
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