SILK SURGICAL SUTURES

FDA Premarket Approval N85143 S004

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

DeviceSILK SURGICAL SUTURES
Generic NameSuture, Nonabsorbable, Silk
ApplicantSHARPOINT, INC.
Date Received1987-06-03
Decision Date1988-08-31
PMAN85143
SupplementS004
Product CodeGAP 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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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