DILAPAN(TM)

FDA Premarket Approval P840045 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

DeviceDILAPAN(TM)
Generic NameDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
ApplicantMEDICEM TECHNOLOGY S.R.O
Date Received1987-08-21
Decision Date1987-12-14
PMAP840045
SupplementS003
Product CodeLOB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address MEDICEM TECHNOLOGY S.R.O karlovarsha Trida 20 kamenne Zehrovice 27301

Supplemental Filings

Supplement NumberDateSupplement Type
P840045Original Filing
S006 2000-03-31 Normal 180 Day Track
S005
S004
S003 1987-08-21 Normal 180 Day Track
S002 1987-08-04 Normal 180 Day Track
S001

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