TELECTRONICS PASAR MODEL 4171 PG

Pulse-generator, Single Chamber, Single

FDA Premarket Approval P850027 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

DeviceTELECTRONICS PASAR MODEL 4171 PG
Classification NamePulse-generator, Single Chamber, Single
Generic NamePulse-generator, Single Chamber, Single
ApplicantTELECTRONICS, INC.
Date Received1989-04-02
Decision Date1989-04-18
PMAP850027
SupplementS002
Product CodeLWW
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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