TELIGEN
FDA premarket approval P960040/S213 · decided 2010-03-12
Approval details
- PMA number
- P960040
- Supplement
- S213
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-01-22
- Decision date
- 2010-03-12
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE SECOND SUPPLIER WITH A DESIGN CHANGE FOR THE CAPACITORS USED IN THE COGNIS/TELIGEN FAMILY OF DEVICES.
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