LASTAC SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Premarket Approval P870071 S002

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

DeviceLASTAC SYSTEM
Classification NameDevice, Angioplasty, Laser, Coronary
Generic NameDevice, Angioplasty, Laser, Coronary
ApplicantG V MEDICAL, INC,
Date Received1988-12-12
Decision Date1989-04-04
PMAP870071
SupplementS002
Product CodeLPC
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address G V MEDICAL, INC, 3750 Annapolis Ln. minneapolis, MN 55441

Supplemental Filings

Supplement NumberDateSupplement Type
P870071Original Filing
S008 1990-10-16 Normal 180 Day Track
S007 1990-01-11 Normal 180 Day Track
S006 1989-08-22 Normal 180 Day Track
S005 1989-03-13 Normal 180 Day Track
S004 1988-12-12 Normal 180 Day Track
S003 1988-12-12 Normal 180 Day Track
S002 1988-12-12 Normal 180 Day Track
S001 1988-12-12 Normal 180 Day Track

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