TELECTRONICS PASAR MODEL 4171 PG

Pulse-generator, Single Chamber, Single

FDA Premarket Approval P850027 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

• Device: TELECTRONICS PASAR MODEL 4171 PG
• Classification Name: Pulse-generator, Single Chamber, Single
• Generic Name: Pulse-generator, Single Chamber, Single
• Applicant: TELECTRONICS, INC.
• Date Received: 1987-02-17
• Decision Date: 1987-03-27
• PMA: P850027
• Supplement: S001
• Product Code: LWW
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: TELECTRONICS, INC. 7400 South Tucson Way englewood, CO 80112

Supplemental Filings

Supplement Number	Date	Supplement Type
P850027		Original 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