Approval to change the supplier and specifications of the polyester yarn used to make the mesh of the woven fabric for the flexible occlusion component of the barricaid anular closure device (acd).
Device | Barricaid Anular Closure (ACD) |
Generic Name | Reherniation Reduction Device |
Applicant | INTRINSIC THERAPEUTICS |
Date Received | 2019-03-19 |
Decision Date | 2020-03-17 |
PMA | P160050 |
Supplement | S003 |
Product Code | QES |
Advisory Committee | Orthopedic |
Supplement Type | Real-time Process |
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