|
Device | Barricaid Anular Closure Device |
Generic Name | Reherniation reduction device |
Applicant | INTRINSIC THERAPEUTICS 30 COMMERCE WAY WOBURN, MA 01801 |
PMA Number | P160050 |
Supplement Number | S002 |
Date Received | 03/11/2019 |
Decision Date | 05/03/2019 |
Product Code |
QES |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a manufacturing site for manual lapping and the addition of an automated lapping step. |