ENDOTAK LEAD SYSTEM
FDA premarket approval P910073/S158 · decided 2020-12-04
Approval details
- PMA number
- P910073
- Supplement
- S158
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ENDOTAK LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-10-08
- Decision date
- 2020-12-04
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Labeling updates to the clinical study summary for the post approval study.
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