ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES
FDA premarket approval P910073/S126 · decided 2014-06-30
Approval details
- PMA number
- P910073
- Supplement
- S126
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-06-09
- Decision date
- 2014-06-30
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD THE MODEL 6946 LEAD REPAIR KIT TO THE LIST OF DEVICES TO BE STERILIZED IN THE G8 #3 STERILIZATION CHAMBER.
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