RELIANCE 4-SITE IS-4 LEADS
FDA premarket approval P910073/S099 · decided 2011-11-18
Approval details
- PMA number
- P910073
- Supplement
- S099
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELIANCE 4-SITE IS-4 LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2011-10-21
- Decision date
- 2011-11-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE SETUP POSITION IN A SEAL TEST.
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