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, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/ |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P010047 |
Supplement Number | S039 |
Date Received | 05/28/2015 |
Decision Date | 06/26/2015 |
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 | No |
Recalls | CDRH Recalls |
Approval Order Statement ADD A SECOND SUPPLIER FOR THE BIOBURDEN TESTING, WHICH IS PERFORMED ON A QUARTERLY BASIS TO CONFIRM BIOBURDEN LEVELS PRIOR TO RELEASE OF THE EXTENDED APPLICATOR SPRAY TIPS FOR ETHYLENE OXIDE STERILIZATION REMAIN ACCEPTABLE. |
Post-Approval Study | Show Report Schedule and Study Progress |
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