ENDOTAK RELIANCE TACHY LEAD
FDA premarket approval P910073/S078 · decided 2009-06-10
Approval details
- PMA number
- P910073
- Supplement
- S078
- 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
- 2009-05-08
- Decision date
- 2009-06-10
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE MOLDED TERMINAL LEAD CONNECTOR.
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