TELIGEN FAMILY
FDA premarket approval P960040/S171 · decided 2008-07-25
Approval details
- PMA number
- P960040
- Supplement
- S171
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN FAMILY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-07-03
- Decision date
- 2008-07-25
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL OR CHANGES TO THE PROGRAMMER SW MODEL 2868 V1.03 AND PSEUDO-CONSTANTS LOADED DURING MANUFACTURING OF THE DEVICES.
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