TELIGEN PULSE GENERATORS
FDA premarket approval P960040/S225 · decided 2010-08-06
Approval details
- PMA number
- P960040
- Supplement
- S225
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN PULSE GENERATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-07-13
- Decision date
- 2010-08-06
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE FRONT LINER COMPONENT USED ON THE TELIGEN AND COGNIS PULSE GENERATORS IN THE HYBRID ASSEMBLY AND TO REMOVE THE POLYIMIDE TAPE CURRENTLY APPLIED OVER THE ACCELEROMETER COMPONENT.
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