MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD— 510(k) K851458

Substantially Equivalent

Intermedics, Inc.

FDA 510(k) clearance K851458 for MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD, Substantially Equivalent on 1985-07-11. Applicant: Intermedics, Inc..

Clearance details

Applicant: Intermedics, Inc.
Product code: Code DTD
Advisory panel: Cardiovascular
Date received: 1985-04-11
Decision date: 1985-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freeport, TX, US

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