ENDOTAK RELIANCE AND ENDOTAK ENDURANCE
FDA premarket approval P910073/S055 · decided 2005-11-15
Approval details
- PMA number
- P910073
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK RELIANCE AND ENDOTAK ENDURANCE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-10-06
- Decision date
- 2005-11-15
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE DRUG PLUG COMPONENT OF THE LEADS FROM ONE YEAR TO THREE YEARS. THE SHELF LIFE OF THE FINISHED LEADS REMAINS TWO YEARS.
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