TELIGEN 4-SITE HEADER ICD MODELS
FDA premarket approval P960040/S262 · decided 2012-12-21
Approval details
- PMA number
- P960040
- Supplement
- S262
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- TELIGEN 4-SITE HEADER ICD MODELS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-05-14
- Decision date
- 2012-12-21
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
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