ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS
FDA premarket approval P910073/S128 · decided 2014-11-04
Approval details
- PMA number
- P910073
- Supplement
- S128
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-09-03
- Decision date
- 2014-11-04
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ACUITY X4 CONNECTOR TOOL MODEL 4625 ACCESSORY.
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