PRIZM, PRIZM II CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)
FDA premarket approval P960040/S143 · decided 2007-09-19
Approval details
- PMA number
- P960040
- Supplement
- S143
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRIZM, PRIZM II CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-02-12
- Decision date
- 2007-09-19
- Days to decision
- 219 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER FOR INTEGRATED CIRCUIT WAFER GOLD BUMPING SERVICE FOR THE PRIZM AND PRIZM II CRT-D DEVICES.
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