TELIGEN ICDS
FDA premarket approval P960040/S195 · decided 2009-06-12
Approval details
- PMA number
- P960040
- Supplement
- S195
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-04-30
- Decision date
- 2009-06-12
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE RF MODULE CHANGES FOR COGNIS/TELIGEN MODELS E102, E110, N108, N118, AND N119.
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