RELIANCE FAMILY OF LEADS
FDA premarket approval P910073/S073 · decided 2008-10-31
Approval details
- PMA number
- P910073
- Supplement
- S073
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELIANCE FAMILY OF LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-05-02
- Decision date
- 2008-10-31
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ADDITIONAL INSPECTION STEPS.
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