ENDOTAK RELIANCE FAMILY OF LEADS
FDA premarket approval P910073/S062 · decided 2006-04-28
Approval details
- PMA number
- P910073
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK RELIANCE FAMILY OF LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-01-06
- Decision date
- 2006-04-28
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A TOLERANCE CHANGE TO THE ELECTRODE BASE DIAMETER, AN INCREASE IN THE ELECTRODE BASE DIAMETER, A TOLERANCE CHANGE TO THE ELECTRODE SHELL BEARING SURFACES, AND A MODIFICATION TO THE O-RING SEAT IN THE ELECTRODE SHELL TO ALL ACTIVE-FIXATION ENDOTAK RELIANCE LEADS.
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