INTERTACH(R)II MODELS 262-16
FDA premarket approval P860007/S017 · decided 1996-03-22
Approval details
- PMA number
- P860007
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTERTACH(R)II MODELS 262-16
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Applicant
- Boston Scientific
- Date received
- 1996-02-01
- Decision date
- 1996-03-22
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LWW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE INTRODUCTION OF LABELNG ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:INTERTACH II 262-16/262-16R
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