VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA premarket approval P910077/S121 · decided 2012-06-19
Approval details
- PMA number
- P910077
- Supplement
- S121
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-05-09
- Decision date
- 2012-06-19
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE OPTION TO CONNECT THE LATTITUDE COMMUNICATOR TO AN OFF-THE-SHELF COMMERCIALLY AVAILABLE CELLULAR MODEM.
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