TELECTRONICS PASAR MODEL 4171 PG

Pulse-generator, Single Chamber, Single

FDA Premarket Approval P850027 S005

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

DeviceTELECTRONICS PASAR MODEL 4171 PG
Classification NamePulse-generator, Single Chamber, Single
Generic NamePulse-generator, Single Chamber, Single
ApplicantTELECTRONICS, INC.
Date Received1990-01-16
Decision Date1990-02-02
PMAP850027
SupplementS005
Product CodeLWW
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address TELECTRONICS, INC. 7400 South Tucson Way englewood, CO 80112

Supplemental Filings

Supplement NumberDateSupplement Type
P850027Original Filing
S006 1990-04-19 Normal 180 Day Track
S005 1990-01-16 Normal 180 Day Track
S004
S003 1989-11-02 Normal 180 Day Track
S002 1989-04-02 Normal 180 Day Track
S001 1987-02-17 Normal 180 Day Track

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