TELIGEN 4-SITE MODELS
FDA premarket approval P960040/S198 · decided 2010-11-10
Approval details
- PMA number
- P960040
- Supplement
- S198
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN 4-SITE MODELS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-05-11
- Decision date
- 2010-11-10
- Days to decision
- 548 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR: 1) THE ELEVATED PRESSURE LABELING MODIFICATIONS FOR TELIGEN ICD MODELS E103, E111, E102 AND E110; AND 2) THE NEW 4-SITE HEADER FOR TELIGEN ICD MODELS E103 AND E111.
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