CONTAK CD/CD2/RENEWAL /RENEWAL 3
FDA premarket approval P010012/S142 · decided 2007-02-08
Approval details
- PMA number
- P010012
- Supplement
- S142
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CONTAK CD/CD2/RENEWAL /RENEWAL 3
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2006-11-01
- Decision date
- 2007-02-08
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.
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