PREVELLE SILK

FDA Premarket Approval P030032 S013

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.

Pre-market Approval Supplement Details

Addition of a raw material identification system and an automated filter integrity test instrument.

DevicePREVELLE SILK
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantGENZYME BIOSURGERY
Date Received2011-09-02
Decision Date2011-10-07
PMAP030032
SupplementS013
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GENZYME BIOSURGERY 55 Cambridge Parkway cambridge, MA 02142

Supplemental Filings

Supplement NumberDateSupplement Type
P030032Original Filing
S017 2014-08-08 30-day Notice
S016 2013-09-25 135 Review Track For 30-day Notice
S015
S014 2011-12-20 135 Review Track For 30-day Notice
S013 2011-09-02 30-day Notice
S012 2011-05-27 Real-time Process
S011
S010 2010-06-09 135 Review Track For 30-day Notice
S009 2009-09-11 30-day Notice
S008 2009-04-15 Normal 180 Day Track No User Fee
S007 2007-07-25 Normal 180 Day Track
S006
S005 2006-01-27 Normal 180 Day Track No User Fee
S004 2005-09-23 Real-time Process
S003 2005-04-20 Normal 180 Day Track No User Fee
S002 2004-07-28 Normal 180 Day Track
S001 2004-06-22 Panel Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.