ENDOTAK RELIANCE G/SG with 4-SITE Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 0283
FDA premarket approval P910073/S134 · decided 2016-04-27
Approval details
- PMA number
- P910073
- Supplement
- S134
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK RELIANCE G/SG with 4-SITE Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 0283
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-04-06
- Decision date
- 2016-04-27
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implementation of a new laser weld system.
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