TELIGEN PULSE GENERATORS
FDA premarket approval P960040/S214 · decided 2010-04-02
Approval details
- PMA number
- P960040
- Supplement
- S214
- 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
- 2010-03-15
- Decision date
- 2010-04-02
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR 2ND SUPPLIER (IXYS) TO PROVIDE SCR/ANODE GATE THYRISTORS FOR THE SUPER OUTPUT MODULE (SOM) OF THE COGNIS/TELIGEN PGS.
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