PMA P910020S021

Device: COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S021
Product code: DXY
Decision date: 1998-05-21
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for the following pacemakers which incorporate the Edgebadn Design: Cosmos 3 Model 284-09E; Cosmos II Model 284-05E; Stride Model 294-05E; Dash Model 292-03E; Dart Model 292-05E; Unity Model 292-07E; Nova III Model 282-07E; and the Quantum III Model 254-27E. Supplement is approved for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the folowing additional models: the Side-Lock(TM) implantable pulse generator models 282-07, 254-27, and 254-31, and the Nova II Model 281-05 and Nova III Model 282-04 pulse generators.

Current openFDA PMA Record

Device: COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S021
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1998-05-21
Decision code: APPR
Date received: 1998-02-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the following pacemakers which incorporate the Edgebadn Design: Cosmos 3 Model 284-09E; Cosmos II Model 284-05E; Stride Model 294-05E; Dash Model 292-03E; Dart Model 292-05E; Unity Model 292-07E; Nova III Model 282-07E; and the Quantum III Model 254-27E. Supplement is approved for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the folowing additional models: the Side-Lock(TM) implantable pulse generator models 282-07, 254-27, and 254-31, and the Nova II Model 281-05 and Nova III Model 282-04 pulse generators.