TELIGEN PULSE GENERATORS
FDA premarket approval P960040/S224 · decided 2010-10-15
Approval details
- PMA number
- P960040
- Supplement
- S224
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TELIGEN PULSE GENERATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-08-16
- Decision date
- 2010-10-15
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF SECOND SOURCE DIODE SUPPLIERS (ST MICRO AND MINCO TECHNOLOGY LABS) FOR THE HCVM AND SOM USED IN THE COGNIS AND TELIGEN PULSE GENERATORS.
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