ENDOTAK RELIANCE IS-1 LEAD
FDA premarket approval P910073/S143 · decided 2017-06-30
Approval details
- PMA number
- P910073
- Supplement
- S143
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK RELIANCE IS-1 LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-06-07
- Decision date
- 2017-06-30
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implementation of serial number reading stations with optical character recognition equipment and software for use in lead manufacturing.
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