ENDOTAK RELIANCE TACHY LEAD
FDA premarket approval P910073/S097 · decided 2011-06-02
Approval details
- PMA number
- P910073
- Supplement
- S097
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK RELIANCE TACHY LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2011-05-04
- Decision date
- 2011-06-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- REDUCTION IN SAMPLE SIZE
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