VENTAK(R) PRIZM(TM) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD-TM) SYSTEM
FDA premarket approval P960040/S020 · decided 2001-02-01
Approval details
- PMA number
- P960040
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK(R) PRIZM(TM) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD-TM) SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-12-26
- Decision date
- 2001-02-01
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MODIFICATION OF THE PRIZM AICD HEADER.
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