PMA P020041S002

Device
FEM CAP
Applicant
Femcap Incorporated
PMA number
P020041
Supplement
S002
Product code
LLQ
Decision date
2011-10-13
Generic name
Cap, cervical, contraceptive
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT HELIX MEDICAL, LLC. IN CARPINTERIA, CA93013

Current openFDA PMA Record#

Device
FEM CAP
Applicant
Femcap Incorporated
PMA number
P020041
Supplement
S002
Product code
LLQ
Generic name
Cap, cervical, contraceptive
Decision date
2011-10-13
Decision code
APPR
Date received
2011-07-14
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT HELIX MEDICAL, LLC. IN CARPINTERIA, CA93013