LAMICEL OSMOTIC CERVICAL DILATOR

FDA Premarket Approval P820075 S008

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

The 30-day notice requested a change in the approved sterilization process of e-beam to gamma radiation process.

DeviceLAMICEL OSMOTIC CERVICAL DILATOR
Generic NameDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
ApplicantMedtronic Xomed, Inc.
Date Received1999-06-24
Decision Date1999-07-09
PMAP820075
SupplementS008
Product CodeLOB 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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