VENTAK AND CONTAK CD FAMILIES OF ICDS
FDA premarket approval P960040/S114 · decided 2006-04-12
Approval details
- PMA number
- P960040
- Supplement
- S114
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK AND CONTAK CD FAMILIES OF ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-03-06
- Decision date
- 2006-04-12
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE VENTAK (P960040) AND CONTAK CD (P010012) FAMILIES OF IMPLANTABLE DEFIBRILLATORS TO INCLUDE INFORMATION REGARDING BEHAVIOR OF THESE DEVICES ATTRIBUTABLE TO THE SVO (SILVER VANADIUM OXIDE) USED TO POWER THEM. SPECIFICALLY, AN UPDATE TO THE SYSTEM GUIDE TO INCLUDE LANGUAGE TO IDENTIFY AS NORMAL AN INCREASED CHARGED TIME IN MIDLIFE DUE TO THE INHERENT CHARACTERISTICS OF THE SVO BATTERIES USED.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.