ENDOTAK RELIANCE G/SG LEADS
FDA premarket approval P910073/S061 · decided 2005-12-30
Approval details
- PMA number
- P910073
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK RELIANCE G/SG LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-12-02
- Decision date
- 2005-12-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN MANUFACTURING PROCESS THAT IMPROVES THE DISTAL COIL BONDING PROCESS BY 1) CHANGING THE CONSTITUTION OF THE BONDING ADHESIVE, 2) CHANGING THE TOOL USED TO APPLY THE BONDING ADHESIVE, AND 3) ADDING DIAGRAMS TO THE MANUFACTURING INSTRUCTIONS FOR THE LEADS.
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