LAMICEL OSMOTIC CERVICAL DILATOR

FDA Premarket Approval P820075 S009

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 new sterilization facility located at sterigenics intl. , inc. , 10811 withers cove park dr. , charlotte, n. C.

DeviceLAMICEL OSMOTIC CERVICAL DILATOR
Generic NameDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
ApplicantMedtronic Xomed, Inc.
Date Received1999-06-24
Decision Date1999-07-16
PMAP820075
SupplementS009
Product CodeLOB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonExpress Gmp Supplement
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Xomed, Inc. 6743 Southpoint Dr. N. jacksonville, FL 32216

Supplemental Filings

Supplement NumberDateSupplement Type
P820075Original Filing
S009 1999-06-24 Normal 180 Day Track
S008 1999-06-24 30-day Notice
S007 1995-05-22 Normal 180 Day Track
S006 1995-05-12 Normal 180 Day Track
S005 1991-07-05 Normal 180 Day Track
S004 1988-01-11 Normal 180 Day Track
S003
S002 1984-12-03
S001 1984-12-03

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