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 | RESURE SEALANT |
Generic Name | Ophthalmic Sealant |
Applicant | OCULAR THERAPEUTIX, INC. 36 CROSBY DR SUITE 101 BEDFORD, MA 01730 |
PMA Number | P130004 |
Supplement Number | S005 |
Date Received | 09/09/2014 |
Decision Date | 10/10/2014 |
Product Code |
PFZ |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CRITICAL SUPPLIER LOCATION CHANGE- ADDITIONAL FACILITY FOR JENKEM. |
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