SUTURES

FDA Premarket Approval N85143 S001

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

DeviceSUTURES
Generic NameSuture, Nonabsorbable, Silk
ApplicantSHARPOINT, INC.
Date Received1984-12-26
Decision Date1986-10-27
PMAN85143
SupplementS001
Product CodeGAP 
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address SHARPOINT, INC. 824 Twelfth Ave. bethlehem, PA 18018

Supplemental Filings

Supplement NumberDateSupplement Type
N85143Original Filing
S007 1988-06-21 Normal 180 Day Track
S006 1988-02-16 Normal 180 Day Track
S005 1987-09-10 Normal 180 Day Track
S004 1987-06-03 Normal 180 Day Track
S003 1987-05-27 Normal 180 Day Track
S002 1987-02-13 Normal 180 Day Track
S001 1984-12-26

NIH GUDID Devices

Device IDPMASupp
10848782013026 N85143 007

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