- Device
- COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S071
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- 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 whcih incorporate the Edgeband 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 theQuantum III Model 254-27E. In addition approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the following 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.