FEM CAP

FDA Premarket Approval P020041 S002

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 a manufacturing site located at helix medical, llc. In carpinteria, ca93013

DeviceFEM CAP
Generic NameCap, Cervical, Contraceptive
ApplicantFEMCAP, INC.
Date Received2011-07-14
Decision Date2011-10-13
PMAP020041
SupplementS002
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

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