ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM
FDA premarket approval P910073/S030 · decided 2000-02-23
Approval details
- PMA number
- P910073
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-01-11
- Decision date
- 2000-02-23
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- All previously marketed Intermedics stylets to be marketed under new Guidant model numbers 6032-6066,6765-6770,6826,6828,6963,6964,6971,6972,6983,and 6985. Also approved an alternate stylet kit package insert
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