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 | Progel Pleural Air Leak Sealant |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P010047 |
Supplement Number | S059 |
Date Received | 06/27/2018 |
Decision Date | 07/26/2018 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Change to the radiation dose used for the sterile Nalgene plastic containers used to store and deliver the Polyethylene Glycol Disuccinimidyl Succinate (PEG(SS)2) raw material to Neomend. |
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