ENDOTAK RELIANCE SYSTEM
FDA premarket approval P910073/S140 · decided 2017-01-10
Approval details
- PMA number
- P910073
- Supplement
- S140
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK RELIANCE SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-12-14
- Decision date
- 2017-01-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Additional supplier of molded components.
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