COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
FDA premarket approval P830026/S071 · decided 1998-05-21
Approval details
- PMA number
- P830026
- Supplement
- S071
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-02-19
- Decision date
- 1998-05-21
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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
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