Modifications to the introducer sheath
Device | Bulkamid Urethral Bulking System |
Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
Applicant | Contura International A/S |
Date Received | 2020-05-05 |
Decision Date | 2020-06-02 |
PMA | P170023 |
Supplement | S001 |
Product Code | LNM |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Contura International A/S sydmarken 23 soeborg 2860 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P170023 | | Original Filing |
S013 |
2022-09-27 |
30-day Notice |
S012 |
2022-09-27 |
30-day Notice |
S011 |
2022-07-08 |
30-day Notice |
S010 |
2022-07-08 |
30-day Notice |
S009 |
2022-07-08 |
30-day Notice |
S008 |
2020-12-18 |
30-day Notice |
S007 |
2020-11-24 |
30-day Notice |
S006 | | |
S005 |
2020-09-04 |
Real-time Process |
S004 | | |
S003 |
2020-08-13 |
Real-time Process |
S002 | | |
S001 |
2020-05-05 |
30-day Notice |
NIH GUDID Devices