FEMCAP

FDA Premarket Approval P020041 S003

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

Approval for kdl precision molding corporation, a manufacturing site located in pacoima, california

DeviceFEMCAP
Generic NameCap, Cervical, Contraceptive
ApplicantFEMCAP, INC.
Date Received2013-03-08
Decision Date2013-08-21
PMAP020041
SupplementS003
Product CodeLLQ 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address FEMCAP, INC. 14058 Mira Montana Dr. del Mar, CA 92014-3455

Supplemental Filings

Supplement NumberDateSupplement Type
P020041Original Filing
S003 2013-03-08 Normal 180 Day Track No User Fee
S002 2011-07-14 Normal 180 Day Track No User Fee
S001 2005-09-02 Real-time Process

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