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.
Device | INSTAT COLLAGEN ABSORBABLE HEMOSTAT |
Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
Applicant | ETHICON, INC. |
Date Received | 1990-05-07 |
Decision Date | 1990-09-12 |
PMA | P830079 |
Supplement | S009 |
Product Code | LMF |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | ETHICON, INC. route 22 West p.o. Box 151 somerville, NJ 08876-0151 |
Supplement Number | Date | Supplement Type |
---|---|---|
P830079 | Original Filing | |
S017 | 2007-06-01 | Normal 180 Day Track |
S016 | 2005-06-24 | Normal 180 Day Track No User Fee |
S015 | 2004-04-28 | Normal 180 Day Track No User Fee |
S014 | 2003-08-25 | Real-time Process |
S013 | ||
S012 | 1998-08-28 | Normal 180 Day Track |
S011 | 1995-06-13 | Normal 180 Day Track |
S010 | 1990-05-25 | Normal 180 Day Track |
S009 | 1990-05-07 | Normal 180 Day Track |
S008 | 1990-04-26 | Normal 180 Day Track |
S007 | 1988-09-26 | Normal 180 Day Track |
S006 | 1988-05-31 | Normal 180 Day Track |
S005 | ||
S004 | ||
S003 | 1986-10-24 | Normal 180 Day Track |
S002 | 1986-09-09 | Normal 180 Day Track |
S001 | 1985-11-07 |