Approval for the addition of a manufacturing site for manual lapping and the addition of an automated lapping step.
Device | Barricaid Anular Closure |
Classification Name | Reherniation Reduction Device |
Generic Name | Reherniation Reduction Device |
Applicant | INTRINSIC THERAPEUTICS |
Date Received | 2019-03-11 |
Decision Date | 2019-05-03 |
PMA | P160050 |
Supplement | S002 |
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 | No |
Combination Product | No |
Applicant Address | INTRINSIC THERAPEUTICS 30 Commerce Way woburn, MA 01801 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P160050 | | Original Filing |
S006 |
2020-04-22 |
Normal 180 Day Track No User Fee |
S005 |
2020-04-16 |
Normal 180 Day Track No User Fee |
S004 | | |
S003 |
2019-03-19 |
Real-time Process |
S002 |
2019-03-11 |
135 Review Track For 30-day Notice |
S001 |
2019-03-08 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices